This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Risedronate in Osteopenic Postmenopausal Women (OSMAUSE)

This study has been completed.
Procter and Gamble
Information provided by:
Sanofi Identifier:
First received: March 20, 2006
Last updated: December 4, 2009
Last verified: December 2009

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.

Condition Intervention Phase
Osteoporosis Drug: risedronate Drug: risedronate placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Non-invasive Evaluation of Bone Microarchitecture Modification in Osteopenic Postmenopausal Women by 3D Peripheral Quantitative Computed Tomography: A 24 Month, Monocenter Study Comparing Weekly Oral Risedronate 35 mg and Placebo

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Efficacy data : 3-D-pQCT Data—Microarchitectural Parameters (Distal Radius BV/TV Measurements) [ Time Frame: BV/TV percent change from Baseline at distal radius as measured in the non dominant wrist at Month 12 ]

Secondary Outcome Measures:
  • Tolerance data :collection of AEs, with special interest for upper gastrointestinal (UGI) AEs and clinical fractures [ Time Frame: at all visits ]

Estimated Enrollment: 156
Study Start Date: March 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: risedronate
risedronate sodium 35 mg tablets (once a week dose)
Placebo Comparator: 2 Drug: risedronate placebo
placebo for risedronate tablets (once a week dose)


Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Osteopenic, postmenopausal women, between 55 and 75 years of age with a body mass index (BMI) < 30 kg/m²

Exclusion Criteria:

  • Clinical or radiological evidence of osteoporosis
  • Severe renal impairment
  • Serum 5-hydroxy vitamin D level < 15 ng/ml
  • History of recent primary hyperparathyroidism or recent thyroid disorder
  • History of any generalized bone disease
  • Current use of glucocorticoids, estrogens, progestins, calcium supplements > 1 g/day, vitamin D supplements > 800 IU/day, parathyroid hormone (PTH), or any bisphosphonate for > 1 month at any time within the past 6 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00345644

Paris, France
Sponsors and Collaborators
Procter and Gamble
Study Director: Marie SEBILLE, Dr Sanofi
  More Information

Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00345644     History of Changes
Other Study ID Numbers: HMR4003B_3507
EudraCT # :2005-005598-30
Study First Received: March 20, 2006
Last Updated: December 4, 2009

Keywords provided by Sanofi:

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronate Sodium
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Bone Density Conservation Agents
Physiological Effects of Drugs processed this record on June 23, 2017