Risedronate in Osteopenic Postmenopausal Women (OSMAUSE)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Osteoporosis

Treatments: Drug: risedronate; Drug: risedronate placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00345644

EudraCT # :2005-005598-30

HMR4003B_3507

Details and patient eligibility

About

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.

Enrollment: 156 estimated patients

Sex: Female

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: risedronate

2

Placebo Comparator group

Treatment:

Drug: risedronate placebo