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Risedronate in Osteopenic Postmenopausal Women

NCT00345644 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2009-12-07

No results posted yet for this study

Summary

The primary objective of this study is to compare risedronate 35 mg and placebo with respect to the percent change at 12 months for distal radius trabecular bone volume (BV/TV) in osteopenic postmenopausal women, as measured by three-dimensional peripheral quantitative computed tomography (3D pQCT).

The secondary objectives are to compare the percent change from Screening/Baseline between the 2 treatment groups for the following measurements:

* Bone mineral density of the lumbar spine, femoral neck, femoral trochanter, and total proximal femur using a dual energy X-ray absorptiometry (DXA) scan at 12 and 24 months;
* 3D pQCT analysis of distal radius and distal tibia bone microarchitecture data at 6, 12, and 24 months; and
* Bone turnover markers (BTMs) of:

* fasting serum carboxyterminal cross linking telopeptide of type 1 bone collagen (CTX 1);
* serum aminoterminal propeptide of type 1 procollagen (PINP); and
* urine N-telopeptide cross-links (NTX) at 3, 6, 12, and 24 months.

Conditions

Interventions

DRUG

risedronate

risedronate sodium 35 mg tablets (once a week dose)

DRUG

risedronate placebo

placebo for risedronate tablets (once a week dose)

Sponsors & Collaborators

  • Procter and Gamble

    collaborator INDUSTRY

  • Sanofi

    lead INDUSTRY

Principal Investigators

  • Marie SEBILLE, Dr · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00345644 on ClinicalTrials.gov