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PaVOS: PTH and Vibration in OSteoporosis Study

Sponsor
Odense University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02563353
Collaborator
University of Southern Denmark (Other), Copenhagen University Hospital, Denmark (Other), Hospital of South West Denmark (Other), Sygehus Lillebaelt (Other), Odense Patient Data Explorative Network (Other), Region of Southern Denmark (Other)
35
Enrollment
1
Location
3
Arms
48
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objective:

This is a randomized controlled trial (RCT) in osteoporosis patients randomized to standard parathyroid hormone (PTH) treatment alone or to standard PTH treatment and Whole-body vibration (WBV). PTH is an effective but expensive anabolic treatment for osteoporosis. WBV stimulates muscles and bones. A combined treatment might have synergistic or additive beneficial effects on bone, reducing fracture risk making treatment more effective and cost-effective. A beneficial effect on muscles and thereby falls risk of WBV may improve fracture risk even further.

If the results of this pilot study are promising then a strong case can be made for a large multi-centre RCT using strong endpoints including fractures and falls.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

Study Objectives

  1. To determine if WBV in addition to standard PTH treatment has a greater effect on bone mass in osteoporosis patients compared to standard PTH treatment alone.

  2. To determine if WBV in addition to standard PTH treatment has a greater effect on bone microarchitecture in osteoporosis patients compared to standard PTH treatment alone, as assessed by high resolution peripheral quantitative computed tomography (HR-pQCT).

  3. To determine if WBV in addition to standard PTH treatment has a greater effect on markers of bone formation and resorption in osteoporosis patients compared to standard PTH treatment alone.

  4. To study the effects of WBV on muscle function and balance in osteoporosis

  5. To assess the safety and adherence to WBV in osteoporotic patients

Study Design:

General Design This will be a multi-center randomized controlled trial (RCT) in osteoporosis patients being started on standard PTH treatment according to Danish Osteoporosis guidelines. Participants will be randomized to standard PTH treatment alone or to standard PTH treatment and WBV.

Statistical Plan:

Sample Size Determination The inclusion of 32 participants (16 in both groups) would give the study 80% power to detect a clinically significant additional increase of 22% with WBV (assuming a 9% increase of BMD in the PTH alone group and 11% increase in the combined PTH+WBV group, and assuming a SD of the BMD increase of 2%. Allowing for a 20% dropout rate, the plan is to include 40 participants (20 in each group). From previous research on WBV by one of the investigators (TM), statistically significant differences were found in bone formation markers and in muscle strength at 3 months between the WBV and control groups with a sample size of 35. The number of participants in the latter pilot work is reassuringly consistent with the sample size calculations. The number needed to be included is far less (34%) than the actual number of patients treated with PTH in the recruiting departments in a similar time period last year.

Statistical Methods:

STATA/SPSS will be used for data analysis. For the primary endpoint (BMD at 12 months) the mean percentage changes in BMD between the two groups will be compared using Analysis of Variance (ANOVA) provided the distribution is normal. For the other endpoints parametric tests will be used to assess differences in the two groups for normally distributed data and non-parametric tests for data not normally distributed.

The randomization will be done online in the data capture program Red Cap. There will be created a Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, and normal ranges if relevant.

Information:

Participants will be recruited during their attendance at the outpatient clinics. At that time the subjects will be given a full explanation of the study as well as the patient information sheet and invited to participate in the study. At an interval of not less than 24 hours, patients will be invited to consent prior to starting their PTH treatment.

The information will be sufficient for subjects to make an informed decision about their participation in this study. The subject will complete and sign a consent form to indicate they are giving valid consent to participate in the trial.

Withdrawal of Subjects:

Patients who withdraw consent from participation in the trial will be withdrawn from the trial. This will not affect their standard medical management and not cause any adverse effect on the subject.

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
PTH and Vibration in OSteoporosis (PaVOS) Study
Actual Study Start Date :
Nov 1, 2015
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Nov 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: controlgroup

Teriparatide, 20 microgram/day. 24 months of treatment

Drug: teriparatide
Teriparatide, 20 microgram/day. 24 months of treatment.
Other Names:
  • PTH

    		•
    Experimental: studygroup 1

    Teriparatide, 20 microgram/day. 24 months of treatment. 12 months of Whole-body vibration on vibration platforms.

    Other: whole-body vibration
    Whole-body vibration on vibration platforms. 30-40 Hertz, from 2 mm (low) to 4 mm (high) amplitude, 1 minutes x 6 with 1 minute break between. 3 times a week.
    Other Names:
  • vibration therapy

    • Drug: teriparatide
    Teriparatide, 20 microgram/day. 24 months of treatment.
    Other Names:
  • PTH

    		•
    Experimental: studygroup 2

    Teriparatide, 20 microgram/day. 24 months of treatment. 24 months of Whole-body vibration on vibration platforms

    Other: whole-body vibration
    Whole-body vibration on vibration platforms. 30-40 Hertz, from 2 mm (low) to 4 mm (high) amplitude, 1 minutes x 6 with 1 minute break between. 3 times a week.
    Other Names:
  • vibration therapy

    • Drug: teriparatide
    Teriparatide, 20 microgram/day. 24 months of treatment.
    Other Names:
  • PTH

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in the BMD, Bone Mineral Density of hip and spine region (Hologic DXA machine) [at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18, 24 months from baseline]

      DXA scan of hip and spine regions, BMD (g/cm^2)

    Secondary Outcome Measures

    1. Changes in the Bone microarchitecture at the tibia [at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18 and 24 months from baseline]

      HRpQCT assesses parameters of bone microarchitecture at the tibia.

    2. Changes in the Bone microarchitecture at the radius [at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18 and 24 months from baseline]

      HRpQCT assesses parameters of bone microarchitecture at the radius.

    3. changes in muscle mass [at the time the participants start treatment and in an interval as close as possible to after 12 and 24 months from baseline]

      Full body DXA

    4. Changes from baseline in the markers of bone resorption [at the time the participants start treatment and in an interval as close as possible to after 3, 6, 12, 18, 24 months from baseline]

      CTX, sclerostin

    5. Changes from baseline in the markers of bone formation [at the time the participants start treatment and in an interval as close as possible to after 3, 6, 12, 18, 24 months from baseline]

      P1NP

    6. Changes in Muscle strength [at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline]

      Measurements of muscle strength (leg extensor power)

    7. Changes in handgrip strength [at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline]

      Measurements of muscle strength (handgrip strength)

    8. Changes in Balance [at the time the participants start treatment and in an interval as close as possible to after 3, 6 ,12, 18 and 24 months from baseline]

      Short Physical Performance Battery (SPPB)

    9. Adherence to WBV [During 2 years from the start of the treatment]

      Self Reporting training log

    10. Changes in physical activity [at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline]

      IPAQ short version

    11. Changes in quality of life [at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline]

      EQ5D questionaire.

    12. Changes in basic mobility [at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline]

      Time up and go test

    13. Changes in The Falls Efficacy Scale International [at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline]

      FES-I

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Women starting PTH treatment for osteoporosis according to Danish Osteoporosis guidelines
    Exclusion Criteria:

    • Women currently taking oral glucocorticoids

    • Women unable to give informed consent

    • Women unable to stand for 2 minutes at a time on the vibration platform

    • Women who have contraindications to WBV (e.g. joint prosthesis, pacemakers)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Odense University Hospital Odense Denmark 5000

    Sponsors and Collaborators

    • Odense University Hospital
    • University of Southern Denmark
    • Copenhagen University Hospital, Denmark
    • Hospital of South West Denmark
    • Sygehus Lillebaelt
    • Odense Patient Data Explorative Network
    • Region of Southern Denmark

    Investigators

    • Principal Investigator: Lars Matzen, Clin.Ass.Pro, Odense University Hospital
    • Principal Investigator: Ditte Jepsen, MD, ph.d. student, University of Southern Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Lars Matzen, MD, Clin. Ass. Professor, Odense University Hospital
    ClinicalTrials.gov Identifier:
    NCT02563353
    Other Study ID Numbers:
    • S-20150121
    First Posted:
    Sep 30, 2015
    Last Update Posted:
    Sep 18, 2020
    Last Verified:
    Sep 1, 2020
    Keywords provided by Lars Matzen, MD, Clin. Ass. Professor, Odense University Hospital
    whole body vibration
    PTH
    Additional relevant MeSH terms:
    Osteoporosis
    Teriparatide

    Study Results

    No Results Posted as of Sep 18, 2020