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Bone Microarchitecture in Osteopenic Postmenopausal Women

Primary Purpose

Osteoporosis

Status
Terminated
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
placebo
risedronate
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoporosis

Eligibility Criteria

40 Years - 57 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Research Facility
  • Research Facility
  • Research Site
  • Research Facility

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

2

1

Arm Description

one 150 mg risedronate once a month, orally

Placebo tablet once a month, orally

Outcomes

Primary Outcome Measures

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
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

Erosion Index of the Distal Radius
Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.

Full Information

First Posted
December 19, 2007
Last Updated
April 15, 2013
Sponsor
Warner Chilcott
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00577395
Brief Title
Bone Microarchitecture in Osteopenic Postmenopausal Women
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 Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Terminated
Study Start Date
July 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
one 150 mg risedronate once a month, orally
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo tablet once a month, orally
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
oral tablet once a month for 12 months
Intervention Type
Drug
Intervention Name(s)
risedronate
Intervention Description
tablet, 150 mg once a month for 12 months
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana M Balske, MD, PhD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Facility
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Research Facility
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68729
Country
United States
Facility Name
Research Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45201
Country
United States
Facility Name
Research Facility
City
Buenos Aires
Country
Argentina

12. IPD Sharing Statement

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Bone Microarchitecture in Osteopenic Postmenopausal Women

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