Bone Microarchitecture in Osteopenic Postmenopausal Women

Osteoporosis Clinical Trial

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).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00577395
• Other study ID #: 2007075
• Status: Terminated
• Phase: Phase 4
• First received: December 19, 2007
• Last updated: April 15, 2013
• Start date: July 2008
• Est. completion date: February 2009

Study information

• Verified date: April 2013
• Source: Warner Chilcott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 57 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• placebo
oral tablet once a month for 12 months
• risedronate
tablet, 150 mg once a month for 12 months

Locations

Country	Name	City	State
Argentina	Research Facility	Buenos Aires
United States	Research Site	Cincinnati	Ohio
United States	Research Facility	Omaha	Nebraska
United States	Research Facility	Tuscon	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Warner Chilcott	Sanofi

Countries where clinical trial is conducted

United States,  Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months	No
Secondary	Erosion Index of the Distal Radius	Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.	6 months	No