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MOVE: A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT00887354
Collaborator
(none)
224
Enrollment
28
Locations
2
Arms
76
Duration (Months)
8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent pertrochanteric hip fracture.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The study has 3 periods: a screening phase, a double-blind, double-dummy treatment phase from the time of randomization to the 26 weeks visit, and an open-label treatment phase of approximately 12 month duration, where participants will continue treatment with the same study drug that they were randomized to.

Study Design

Study Type:
Interventional
Actual Enrollment :
224 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effects of Teriparatide With Those of Risedronate on Lumbar Spine BMD (Bone Mineral Density) in Men and Postmenopausal Women With Low Bone Mass and a Recent Pertrochanteric Hip Fracture
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Aug 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Teriparatide

20 micrograms (mcg) a day by subcutaneous injection throughout study. Placebo oral tablets once a week, to match the active comparator weekly dose, during the double-blind, double-dummy phase only.

Drug: Teriparatide
Administered subcutaneously
Other Names:
  • Forteo
  • LY333334

    • Drug: Placebo
    Weekly: Administered orally Daily: Administered subcutaneously

    Dietary Supplement: Calcium
    Approximately 500 to 1000 mg/day administered orally throughout study.

    Dietary Supplement: Vitamin D
    Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Active Comparator: Risedronate

    35 milligrams (mg) risedronate sodium orally once weekly throughout study. Daily placebo injection, to match the daily experimental drug dose, during the double-blind, double-dummy phase only.

    Drug: Risedronate
    Administered orally

    Drug: Placebo
    Weekly: Administered orally Daily: Administered subcutaneously

    Dietary Supplement: Calcium
    Approximately 500 to 1000 mg/day administered orally throughout study.

    Dietary Supplement: Vitamin D
    Approximately 800 International Units per day (IU/day) administered orally throughout study.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Lumbar Spine Areal Bone Mineral Density (BMD) [Baseline, Week 78]

      Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).

    Secondary Outcome Measures

    1. Change in Lumbar Spine Areal Bone Mineral Density [Baseline, Week 26; Baseline, Week 52]

      Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).

    2. Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb [Baseline, Week 26; Baseline, Week 52; Baseline, Week 78]

      Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) . Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use.

    3. Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire [Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26]

      SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No).

    4. Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale [Baseline]

      Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous.

    5. Visual Analog Scale (VAS) [6, 12, 18, and 26 Weeks]

      Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction.

    6. Timed "Up and Go" Test [6, 12, 18, and 26 Weeks]

      Timed "Up and Go" test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley's pain score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Men and postmenopausal women aged ≥50 who have sustained a unilateral, fracture of the trochanteric region

    • Lumbar spine BMD and/or femoral neck BMD and/or total hip BMD measurement of the contra lateral hip at least 2.0 SDs (standard deviation) below the average bone mass for young women and men

    Exclusion Criteria:

    • Clinically significant abnormal laboratory values

    • History of unresolved skeletal diseases that affect bone metabolism

    • Polytrauma participants and participants with fractures at more than one site

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fort Lauderdale Florida United States 33316
    2 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New Port Richey Florida United States 34652
    3 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Orlando Florida United States 32804
    4 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. New York New York United States 10075
    5 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Durham North Carolina United States 27710
    6 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Fargo North Dakota United States 58103
    7 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Toronto Ontario Canada M5G 2C4
    8 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Zagreb Croatia 10000
    9 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Klatovy Czechia 33938
    10 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Prague Czechia 140 59
    11 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Odense Denmark 5000
    12 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Viborg Denmark 8800
    13 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Orleans France 45032
    14 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Paris France 75679
    15 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Saint-Etienne France 42055
    16 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Villeurbanne France 69100
    17 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Göttingen Germany 37075
    18 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Thessaloniki Greece 56429
    19 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Milano Italy 20122
    20 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rome Italy 00133
    21 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Mexicali Mexico 21200
    22 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Monterrey Mexico 64460
    23 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Oslo Norway 0407
    24 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Barcelona Spain 08025
    25 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Girona Spain 17007
    26 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Madrid Spain 28041
    27 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Marbella Spain 29600
    28 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Sevilla Spain 41013

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM eastern time (UTC/GMT-5hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT00887354
    Other Study ID Numbers:
    • 12400
    • B3D-EW-GHDK
    First Posted:
    Apr 24, 2009
    Last Update Posted:
    Sep 25, 2019
    Last Verified:
    Sep 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Eli Lilly and Company
    Low bone mass
    Recent pertrochanteric hip fracture
    Additional relevant MeSH terms:
    Osteoporosis
    Hip Fractures
    Vitamin D
    Teriparatide
    Risedronic Acid
    Calcium

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Full Analysis Set (FAS) is defined as all randomized participants receiving at least one dose of study drug with at least one post-baseline efficacy measure.
    Arm/Group Title Teriparatide Risedronate
    Arm/Group Description 20 microgram (mcg) a day by subcutaneous (SC) injection throughout study. Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Period Title: Treatment Phase (Week 0 to Week 26)
    STARTED 111 113
    Received at Least 1 Dose of Study Drug 106 110
    Included in Full Analysis Set 86 85
    COMPLETED 60 65
    NOT COMPLETED 51 48
    Period Title: Treatment Phase (Week 0 to Week 26)
    STARTED 60 65
    COMPLETED 57 59
    NOT COMPLETED 3 6

    Baseline Characteristics

    Arm/Group Title Teriparatide Risedronate Total
    Arm/Group Description 20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. Total of all reporting groups
    Overall Participants 86 85 171
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    77.2
    (7.96)
    76.4
    (7.47)
    76.8
    (7.71)
    Sex: Female, Male (Count of Participants)
    Female
    66
    76.7%
    66
    77.6%
    132
    77.2%
    Male
    20
    23.3%
    19
    22.4%
    39
    22.8%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    White
    86
    100%
    85
    100%
    171
    100%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (participants) [Number]
    Greece
    3
    3.5%
    4
    4.7%
    7
    4.1%
    Canada
    0
    0%
    2
    2.4%
    2
    1.2%
    Czech Republic
    8
    9.3%
    12
    14.1%
    20
    11.7%
    United States
    1
    1.2%
    4
    4.7%
    5
    2.9%
    Norway
    5
    5.8%
    2
    2.4%
    7
    4.1%
    Denmark
    13
    15.1%
    9
    10.6%
    22
    12.9%
    Italy
    16
    18.6%
    10
    11.8%
    26
    15.2%
    Mexico
    6
    7%
    12
    14.1%
    18
    10.5%
    France
    5
    5.8%
    8
    9.4%
    13
    7.6%
    Germany
    2
    2.3%
    1
    1.2%
    3
    1.8%
    Spain
    21
    24.4%
    19
    22.4%
    40
    23.4%
    United Kingdom
    1
    1.2%
    0
    0%
    1
    0.6%
    Austria
    1
    1.2%
    0
    0%
    1
    0.6%
    Ireland
    1
    1.2%
    0
    0%
    1
    0.6%
    Sweden
    3
    3.5%
    2
    2.4%
    5
    2.9%

    Outcome Measures

    1. Primary Outcome
    Title Change in Lumbar Spine Areal Bone Mineral Density (BMD)
    Description Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
    Time Frame Baseline, Week 78

    Outcome Measure Data

    Analysis Population Description
    All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
    Arm/Group Title Teriparatide Risedronate
    Arm/Group Description 20 mg per day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Measure Participants 61 66
    Least Squares Mean (Standard Error) [gram per square centimeter (g/cm^2)]
    0.094
    (0.0075)
    0.055
    (0.0081)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Teriparatide, Risedronate
    Comments
    Type of Statistical Test Superiority or Other (legacy)
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean
    Estimated Value 0.040
    Confidence Interval (2-Sided) 95%
    0.025 to 0.055
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Change in Lumbar Spine Areal Bone Mineral Density
    Description Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline lumbar spine BMD, type of hip fracture (31-A1/31-A2) and glucocorticoids used at baseline (Yes/No).
    Time Frame Baseline, Week 26; Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
    Arm/Group Title Teriparatide Risedronate
    Arm/Group Description 20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Measure Participants 61 66
    Week 26
    0.053
    (0.0074)
    0.032
    (0.0081)
    Week 52
    0.078
    (0.0074)
    0.044
    (0.0081)
    3. Secondary Outcome
    Title Change in Areal Bone Mineral Density Measured at the Femoral Neck and Total Hip of the Non-Fractured Limb
    Description Femoral neck BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline femoral neck BMD and type of hip fracture (31-A1/31-A2) . Total hip BMD: Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for baseline total hip BMD, type of hip fracture (31-A1/31-A2) and duration of prior bisphosphonate use.
    Time Frame Baseline, Week 26; Baseline, Week 52; Baseline, Week 78

    Outcome Measure Data

    Analysis Population Description
    All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
    Arm/Group Title Teriparatide Risedronate
    Arm/Group Description 20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Measure Participants 60 61
    Total Hip 26 Weeks
    -0.001
    (0.0042)
    -0.001
    (0.0042)
    Total Hip 52 Weeks
    0.001
    (0.0042)
    -0.001
    (0.0042)
    Total Hip 78 Weeks
    0.007
    (0.0042)
    0.005
    (0.0043)
    Femoral Neck 26 Weeks
    0.002
    (0.0044)
    -0.009
    (0.0043)
    Femoral Neck 52 Weeks
    -0.000
    (0.0044)
    -0.006
    (0.0044)
    Femoral Neck 78 Weeks
    0.012
    (0.0044)
    -0.007
    (0.0045)
    4. Secondary Outcome
    Title Change From Baseline in Physical Component Summary of the Short Form-36 (SF-36) Questionnaire
    Description SF-36 is a self-reported questionnaire consisting of 36 questions covering 8 health domains. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. The physical component summary (PCS) has been constructed based on the 8 SF-36 domains and consist of the physical functioning, bodily pain, role-physical, and general health scales (range = 0 to 100, with higher scores indicating better health status for functioning). Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of hip fracture (31-A1/31-A2) and adequate reduction (Yes/No).
    Time Frame Baseline, Week 6; Baseline, Week 12; Baseline, Week 18; Baseline, Week 26

    Outcome Measure Data

    Analysis Population Description
    All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
    Arm/Group Title Teriparatide Risedronate
    Arm/Group Description 20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Measure Participants 67 65
    Week 6
    7.37
    (1.065)
    5.10
    (1.087)
    Week 12
    11.32
    (1.207)
    11.09
    (1.208)
    Week 18
    14.37
    (1.256)
    12.81
    (1.260)
    Week 26
    16.34
    (1.278)
    14.36
    (1.258)
    5. Secondary Outcome
    Title Percentage of Participants Reporting Hip Pain in Modification of the Charnley's Pain Scale
    Description Self-reported hip pain scale in which 0=no pain; 1=pain is slight or intermittent, pain on starting to walk but getting less with normal activity; 2=pain occurs only after some activity, disappears quickly with rest; 3=pain is tolerable, permitting limited activity; 4=pain is severe on attempting to walk, prevents all activity; 5=pain is severe and spontaneous.
    Time Frame Baseline

    Outcome Measure Data

    Analysis Population Description
    All randomized participants receiving at least one dose of study drug and having baseline Charnley's Pain Scale data.
    Arm/Group Title Teriparatide Risedronate
    Arm/Group Description 20 mg per day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Measure Participants 85 85
    0-No pain
    9.4
    10.9%
    8.2
    9.6%
    1- Pain slight or intermittent
    4.7
    5.5%
    12.9
    15.2%
    2- Pain occurs only after some activity
    23.5
    27.3%
    20.0
    23.5%
    3- Pain is tolerable
    36.5
    42.4%
    38.8
    45.6%
    4- Pain severe on attempting to walk
    20.0
    23.3%
    15.3
    18%
    5- Pain severe and spontaneous
    5.9
    6.9%
    4.7
    5.5%
    6. Secondary Outcome
    Title Visual Analog Scale (VAS)
    Description Visual analog pain scale is a measurement instrument to measure the level of hip pain. Scores range from 0 to 100 millimeter (mm) with higher score indicating greater pain. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for type of fracture (31-A1/31-A2), type of reduction (open/close), use of opioids (Yes/No), use of non-steroidal anti-inflammatory drugs, adequate reduction (Yes/No) and interaction between treatment and adequate reduction.
    Time Frame 6, 12, 18, and 26 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
    Arm/Group Title Teriparatide Risedronate
    Arm/Group Description 20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Measure Participants 63 62
    Week 6
    16.44
    (3.977)
    23.54
    (4.443)
    Week 12
    9.28
    (4.048)
    19.24
    (4.452)
    Week 18
    6.90
    (4.147)
    18.19
    (4.508)
    Week 26
    4.48
    (4.128)
    13.74
    (4.505)
    7. Secondary Outcome
    Title Timed "Up and Go" Test
    Description Timed "Up and Go" test measures, in seconds, the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Least squares (LS) means obtained from mixed model repeated measures analysis including as fixed effects treatment and time with interaction, further adjusted for age, type of fracture (31-A1/31-A2), type of reduction (open/close), type of walking aid, baseline SF-36 PCS and baseline Charnley's pain score.
    Time Frame 6, 12, 18, and 26 Weeks

    Outcome Measure Data

    Analysis Population Description
    All randomized participants receiving at least one dose of study drug and with at least one post-baseline efficacy measure.
    Arm/Group Title Teriparatide Risedronate
    Arm/Group Description 20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    Measure Participants 79 78
    Week 6
    26.45
    (1.090)
    32.38
    (1.085)
    Week 12
    20.13
    (1.092)
    24.48
    (1.086)
    Week 18
    17.75
    (1.093)
    21.14
    (1.087)
    Week 26
    16.69
    (1.095)
    19.91
    (1.088)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description Received at least one dose of study drug.
    Arm/Group Title Teriparatide Risedronate
    Arm/Group Description 20 mcg a day by SC injection throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study. 35 mg risedronate sodium orally once weekly throughout study. Calcium: Approximately 500 to 1000 mg/day administered orally throughout study. Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study.
    All Cause Mortality
    Teriparatide Risedronate
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Teriparatide Risedronate
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 21/106 (19.8%) 27/110 (24.5%)
    Cardiac disorders
    Bradycardia 0/106 (0%) 0 1/110 (0.9%) 1
    Cardiac failure 1/106 (0.9%) 1 0/110 (0%) 0
    Cardiac failure congestive 0/106 (0%) 0 2/110 (1.8%) 2
    Mitral valve incompetence 0/106 (0%) 0 1/110 (0.9%) 1
    Eye disorders
    Retinal detachment 0/106 (0%) 0 1/110 (0.9%) 2
    Gastrointestinal disorders
    Oedema mouth 0/106 (0%) 0 1/110 (0.9%) 1
    General disorders
    Chest pain 1/106 (0.9%) 1 0/110 (0%) 0
    Death 1/106 (0.9%) 1 1/110 (0.9%) 1
    Device breakage 0/106 (0%) 0 1/110 (0.9%) 1
    Device failure 1/106 (0.9%) 1 0/110 (0%) 0
    Medical device complication 0/106 (0%) 0 1/110 (0.9%) 1
    Hepatobiliary disorders
    Liver disorder 1/106 (0.9%) 1 0/110 (0%) 0
    Infections and infestations
    Gastroenteritis 1/106 (0.9%) 1 0/110 (0%) 0
    Pneumonia 1/106 (0.9%) 1 1/110 (0.9%) 1
    Postoperative wound infection 0/106 (0%) 0 1/110 (0.9%) 1
    Septic shock 1/106 (0.9%) 1 1/110 (0.9%) 1
    Subcutaneous abscess 0/106 (0%) 0 1/110 (0.9%) 1
    Urinary tract infection 1/106 (0.9%) 1 2/110 (1.8%) 2
    Wound infection staphylococcal 1/106 (0.9%) 1 0/110 (0%) 0
    Injury, poisoning and procedural complications
    Fall 6/106 (5.7%) 6 9/110 (8.2%) 9
    Femoral neck fracture 0/106 (0%) 0 1/110 (0.9%) 1
    Femur fracture 0/106 (0%) 0 1/110 (0.9%) 1
    Forearm fracture 1/106 (0.9%) 1 0/110 (0%) 0
    Head injury 0/106 (0%) 0 1/110 (0.9%) 1
    Hip fracture 2/106 (1.9%) 2 4/110 (3.6%) 4
    Humerus fracture 1/106 (0.9%) 1 1/110 (0.9%) 1
    Lumbar vertebral fracture 0/106 (0%) 0 1/110 (0.9%) 1
    Pelvic fracture 0/106 (0%) 0 2/110 (1.8%) 2
    Rib fracture 0/106 (0%) 0 1/110 (0.9%) 1
    Subdural haematoma 0/106 (0%) 0 1/110 (0.9%) 1
    Metabolism and nutrition disorders
    Dehydration 1/106 (0.9%) 1 0/110 (0%) 0
    Hyperglycaemia 1/106 (0.9%) 1 0/110 (0%) 0
    Type 2 diabetes mellitus 1/106 (0.9%) 1 0/110 (0%) 0
    Musculoskeletal and connective tissue disorders
    Arthralgia 3/106 (2.8%) 3 0/110 (0%) 0
    Back pain 1/106 (0.9%) 1 0/110 (0%) 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Pancreatic carcinoma metastatic 0/106 (0%) 0 1/110 (0.9%) 1
    Nervous system disorders
    Amnesia 1/106 (0.9%) 1 0/110 (0%) 0
    Cerebral infarction 0/106 (0%) 0 1/110 (0.9%) 1
    Cerebrovascular accident 0/106 (0%) 0 2/110 (1.8%) 2
    Headache 1/106 (0.9%) 2 0/110 (0%) 0
    Ischaemic stroke 1/106 (0.9%) 1 0/110 (0%) 0
    Monoplegia 1/106 (0.9%) 1 0/110 (0%) 0
    Speech disorder 1/106 (0.9%) 2 0/110 (0%) 0
    Syncope 1/106 (0.9%) 1 1/110 (0.9%) 1
    Psychiatric disorders
    Confusional state 1/106 (0.9%) 1 0/110 (0%) 0
    Delirium 1/106 (0.9%) 1 0/110 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial polyp 1/106 (0.9%) 1 0/110 (0%) 0
    Chronic obstructive pulmonary disease 0/106 (0%) 0 1/110 (0.9%) 1
    Dyspnoea 1/106 (0.9%) 1 0/110 (0%) 0
    Pleural effusion 0/106 (0%) 0 1/110 (0.9%) 1
    Pneumothorax 0/106 (0%) 0 1/110 (0.9%) 1
    Pulmonary embolism 0/106 (0%) 0 1/110 (0.9%) 1
    Vascular disorders
    Aortic stenosis 0/106 (0%) 0 1/110 (0.9%) 1
    Orthostatic hypotension 0/106 (0%) 0 1/110 (0.9%) 1
    Venous thrombosis 0/106 (0%) 0 1/110 (0.9%) 1
    Other (Not Including Serious) Adverse Events
    Teriparatide Risedronate
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 53/106 (50%) 47/110 (42.7%)
    Blood and lymphatic system disorders
    Anaemia 0/106 (0%) 0 2/110 (1.8%) 2
    Gastrointestinal disorders
    Abdominal pain upper 3/106 (2.8%) 3 1/110 (0.9%) 1
    Constipation 2/106 (1.9%) 2 3/110 (2.7%) 3
    Diarrhoea 3/106 (2.8%) 3 0/110 (0%) 0
    Nausea 2/106 (1.9%) 6 0/110 (0%) 0
    Infections and infestations
    Bronchitis 4/106 (3.8%) 4 0/110 (0%) 0
    Gastroenteritis 2/106 (1.9%) 2 0/110 (0%) 0
    Influenza 2/106 (1.9%) 2 1/110 (0.9%) 1
    Nasopharyngitis 2/106 (1.9%) 2 2/110 (1.8%) 2
    Urinary tract infection 7/106 (6.6%) 7 4/110 (3.6%) 7
    Viral infection 3/106 (2.8%) 4 0/110 (0%) 0
    Injury, poisoning and procedural complications
    Fall 7/106 (6.6%) 8 5/110 (4.5%) 5
    Investigations
    Blood creatine phosphokinase increased 2/106 (1.9%) 2 0/110 (0%) 0
    Platelet count increased 2/106 (1.9%) 2 0/110 (0%) 0
    Metabolism and nutrition disorders
    Hypercalcaemia 1/106 (0.9%) 1 2/110 (1.8%) 2
    Musculoskeletal and connective tissue disorders
    Arthralgia 12/106 (11.3%) 16 7/110 (6.4%) 8
    Back pain 3/106 (2.8%) 6 3/110 (2.7%) 3
    Bone pain 0/106 (0%) 0 2/110 (1.8%) 2
    Groin pain 1/106 (0.9%) 1 2/110 (1.8%) 2
    Musculoskeletal pain 2/106 (1.9%) 2 1/110 (0.9%) 1
    Osteoarthritis 2/106 (1.9%) 2 2/110 (1.8%) 2
    Pain in extremity 3/106 (2.8%) 7 2/110 (1.8%) 3
    Nervous system disorders
    Dizziness 2/106 (1.9%) 2 1/110 (0.9%) 1
    Headache 2/106 (1.9%) 2 0/110 (0%) 0
    Psychiatric disorders
    Delirium 2/106 (1.9%) 2 0/110 (0%) 0
    Depression 1/106 (0.9%) 1 3/110 (2.7%) 3
    Insomnia 3/106 (2.8%) 3 1/110 (0.9%) 1
    Renal and urinary disorders
    Urinary incontinence 1/106 (0.9%) 1 2/110 (1.8%) 2
    Reproductive system and breast disorders
    Benign prostatic hyperplasia 0/106 (0%) 0 1/23 (4.3%) 1
    Vulval ulceration 0/106 (0%) 0 1/87 (1.1%) 1
    Vulvovaginal dryness 1/81 (1.2%) 1 0/110 (0%) 0
    Skin and subcutaneous tissue disorders
    Eczema 2/106 (1.9%) 2 0/110 (0%) 0
    Rash 1/106 (0.9%) 1 2/110 (1.8%) 2
    Vascular disorders
    Hypertension 5/106 (4.7%) 5 2/110 (1.8%) 2

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT00887354
    Other Study ID Numbers:
    • 12400
    • B3D-EW-GHDK
    First Posted:
    Apr 24, 2009
    Last Update Posted:
    Sep 25, 2019
    Last Verified:
    Sep 1, 2019