Risedronate in Osteopenic Postmenopausal Women

NCT00345644 | Completed Phase 3

• 2 other identifiers: HMR4003B_3507EudraCT # :2005-005598-30
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief 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

Osteoporosis

Keywords

Postmenopausal

Outcome Measures

Primary Outcomes (1)

• Efficacy data : 3-D-pQCT Data-Microarchitectural Parameters (Distal Radius BV/TV Measurements)

  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

  at all visits

Study Arms (2)

1

EXPERIMENTAL

Drug: risedronate

2

PLACEBO COMPARATOR

Drug: risedronate placebo

Interventions

risedronate DRUG

risedronate sodium 35 mg tablets (once a week dose)

1

risedronate placebo DRUG

placebo for risedronate tablets (once a week dose)

2

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead
• Procter and Gamble: collaborator

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Osteoporosis

Interventions

Risedronic Acid

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marie SEBILLE, Dr

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 20, 2006
• First Posted: June 28, 2006
• Study Start: March 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

FR (1)