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Bone Microarchitecture in Osteopenic Postmenopausal Women

This study has been terminated.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00577395
First received: December 19, 2007
Last updated: April 15, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Osteoporosis
 Drug: placebo
Drug: risedronate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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).

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis
U.S. FDA Resources

Further study details as provided by Warner Chilcott:

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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Study was terminated prior to acquiring any efficacy endpoints. No efficacy analyses were performed.


Enrollment: 13
Study Start Date: July 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 57 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00577395

Locations
United States, Arizona
Research Facility
Tuscon, Arizona, United States, 85704
United States, Nebraska
Research Facility
Omaha, Nebraska, United States, 68729
United States, Ohio
Research Site
Cincinnati, Ohio, United States, 45201
Argentina
Research Facility
Buenos Aires, Argentina
Sponsors and Collaborators
Warner Chilcott
Sanofi
Investigators
Study Director: Ana M Balske, MD, PhD Procter and Gamble
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00577395     History of Changes
Other Study ID Numbers: 2007075
Study First Received: December 19, 2007
Results First Received: November 18, 2009
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013