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Completed

NCT Number: NCT00345644

Risedronate in Osteopenic Postmenopausal Women

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

risedronate

Drug

risedronate sodium 35 mg tablets (once a week dose)

risedronate placebo

Drug

placebo for risedronate tablets (once a week dose)

Primary outcomes

  1. 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 outcomes

  1. Tolerance data :collection of AEs, with special interest for upper gastrointestinal (UGI) AEs and clinical fractures

    Time frame: at all visits

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Collaborators

  • Procter and Gamble

Registry information

Official study 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

Acronym: OSMAUSE

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 28, 2006
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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