Bone Microarchitecture in Osteopenic Postmenopausal Women

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).

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.

Study Overview

• Status: Terminated
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: risedronate; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Phase 4

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Research Facility
• United States
  • Arizona
    • Tuscon, Arizona, United States, 85704
      • Research Facility
  • Nebraska
    • Omaha, Nebraska, United States, 68729
      • Research Facility
  • Ohio
    • Cincinnati, Ohio, United States, 45201
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 57 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Warner Chilcott
• Collaborators: Sanofi
• Investigators: Study Director: Ana M Balske, MD, PhD, Procter and Gamble

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: December 19, 2007
• First Submitted That Met QC Criteria: December 19, 2007
• First Posted (Estimate): December 20, 2007

Study Record Updates

• Last Update Posted (Estimate): April 22, 2013
• Last Update Submitted That Met QC Criteria: April 15, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Risedronic Acid
• Other Study ID Numbers: 2007075