Bone Microarchitecture in Osteopenic Postmenopausal Women

• Sponsor: Warner Chilcott (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00577395
• Collaborator: Sanofi (Industry)
• Enrollment: 13
• Locations: 4
• Arms: 2
• Duration (Months): 7.1
• Patients Per Site: 3.3
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

The purpose of this trial is to compare the difference in bone microarchitecture of the distal radius at month 12 in postmenopausal osteopenic women treated with risedronate 150mg taken once a month compared to placebo.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: placebo; Drug: risedronate	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 12-month, Multicenter, Double-blind, Randomized, Parallel Group Study Comparing 150 mg Once-a-month Risedronate and Placebo Using 3-dimensional Micro MRI (Magnetic Resonance Imaging).
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 2 one 150 mg risedronate once a month, orally	Drug: risedronate; tablet, 150 mg once a month for 12 months
Placebo Comparator: 1 Placebo tablet once a month, orally	Drug: placebo; oral tablet once a month for 12 months

Outcome Measures

Primary Outcome Measures

1. Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius [12 months]

   The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF). NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed.

Secondary Outcome Measures

1. Erosion Index of the Distal Radius [6 months]

   Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 57 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Female: 40 and 57 years of age inclusive

• cessation of menstruation (surgical or natural) between 12 and 36 months prior to study enrollment

• have osteopenia defines as having the following: have osteopenia defined as having the following:

• Lumbar spine (L1-L4) Bone Mineral Density (BMD) T score -1 and less than -2.5 AND a total hip T score of greater than -2.5 OR

• Lumbar spine (L1-L4) BMD T score greater than -2.5 AND a total hip T score -1 and less than -2.5;

• have a body mass index (BMI) between 18 and 30 kg/m2.

Exclusion Criteria:

• history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia

• use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone

• hypocalcemia or hypercalcemia of any cause

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Facility	Tuscon	Arizona	United States	85704
2	Research Facility	Omaha	Nebraska	United States	68729
3	Research Site	Cincinnati	Ohio	United States	45201
4	Research Facility	Buenos Aires		Argentina

Sponsors and Collaborators

• Warner Chilcott
• Sanofi

Investigators

• Study Director: Ana M Balske, MD, PhD, Procter and Gamble

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Warner Chilcott
• ClinicalTrials.gov Identifier: NCT00577395
• Other Study ID Numbers: 2007075
• First Posted: Dec 20, 2007
• Last Update Posted: Apr 22, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Osteoporosis; Risedronic Acid

Study Results

Participant Flow

Recruitment Details	Beginning with the first patient screened on June 18th, 2008, a total of 51 patients were screened for inclusion into the study, of which 38 were excluded from further participation.
Pre-assignment Detail	The Screening visit was conducted within 45 days of randomization. After obtaining written informed consent, patients underwent a preliminary screening, including Dual Energy X-ray Absorptiometry (DXA) of the lumbar spine and proximal femur. The most frequent reason for screening failure was DXA results.

Arm/Group Title	One 150 mg Risedronate Once a Month	Placebo Tablet Once a Month
Arm/Group Description	one 150 mg risedronate once a month, orally	Placebo tablet once a month, orally
Period Title: Overall Study
STARTED	7	6
COMPLETED	0	0
NOT COMPLETED	7	6

Baseline Characteristics

Arm/Group Title	One 150 mg Risedronate Once a Month	Placebo Tablet Once a Month	Total
Arm/Group Description	one 150 mg risedronate once a month, orally	Placebo tablet once a month, orally	Total of all reporting groups
Overall Participants	7	6	13
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	7 100%	6 100%	13 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.42 (2.50)	53.83 (2.63)	52.53 (2.75)
Sex: Female, Male (Count of Participants)
Female	7 100%	6 100%	13 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	5 71.4%	3 50%	8 61.5%
Argentina	2 28.6%	3 50%	5 38.5%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in Erosion Index (A Ratio of Curve-like Structures to Plate-like Structures and is a Measure of the Degree of Structural Degradation) of the Distal Radius
Description	The percent was change from baseline in erosion index at the distal radius between the risedronate and placebo groups at Month 12 (the lower the percent change in erosion index, the greater the improvement of structural degradation); the last valid postbaseline measurement was to be used when the Month 12 value was missing (Last Observation Carried Forward or LOCF). NOTE: The study was unable to recruit sufficient numbers of patients to meet with the protocol specified numbers, thus it was terminated early after 5 months. No efficacy analyses were performed.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.

Arm/Group Title	One 150 mg Risedronate Once a Month	Placebo Tablet Once a Month
Arm/Group Description	one 150 mg risedronate once a month, orally	Placebo tablet once a month, orally
Measure Participants	0	0

2. Secondary Outcome

Title	Erosion Index of the Distal Radius
Description	Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.

Arm/Group Title	One 150 mg Risedronate Once a Month	Placebo Tablet Once a Month
Arm/Group Description	one 150 mg risedronate once a month, orally	Placebo tablet once a month, orally
Measure Participants	0	0

Adverse Events

Time Frame	From the point of study enrolment until the subject's last observation.
Adverse Event Reporting Description	Specific safety parameters and procedures were to include vital signs, serum chemistry panel/hematology/urinalysis, and recording of AEs, including moderate-to-severe upper GI events and clinical fractures.
Arm/Group Title	One 150 mg Risedronate Once a Month		Placebo Tablet Once a Month
Arm/Group Description	one 150 mg risedronate once a month, orally		Placebo tablet once a month, orally
All Cause Mortality
	One 150 mg Risedronate Once a Month		Placebo Tablet Once a Month
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	One 150 mg Risedronate Once a Month		Placebo Tablet Once a Month
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	One 150 mg Risedronate Once a Month		Placebo Tablet Once a Month
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/7 (28.6%)		2/6 (33.3%)
Cardiac disorders
Blood pressure increased	1/7 (14.3%)	1	0/6 (0%)	0
Gastrointestinal disorders
Abdominal distension	0/7 (0%)	0	1/6 (16.7%)	1
General disorders
Pharyngitis	0/7 (0%)	0	1/6 (16.7%)	1
Infections and infestations
Ear infection	1/7 (14.3%)	1	0/6 (0%)	0

Limitations/Caveats

NOTE: The study was terminated early (after 5 months), prior to acquiring any efficacy endpoints; consequently, NO subject efficacy analyses were performed

More Information

Certain Agreements

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

The Study Site and Principal Investigator agree that all data, calculations, interpretations, opinions, and recommendations regarding the study will be the property of the Sponsor. The Study Site and Principal Investigator agree to consider the results as confidential information subject to use restrictions. The names of the Investigator(s) will not be used by P&GP for commercial purposes without appropriate written permission, unless required by law or government regulation.