Risedronate in the Prevention of Osteoporosis in Postmenopausal Women

Sanofi

Status and phase

Completed

Phase 4

Conditions

Osteoporosis, Postmenopausal

Treatments

Drug: Risedronate (HMR4003)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00402441

HMR4003F/4001

Details and patient eligibility

About

Primary Objective:

To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining bone mineral density (BMD) of the lumbar spine after 1 year of treatment in women who are non-osteoporotic and 0.5-5 years postmenopausal.

Secondary objectives:

To demonstrate that risedronate 35-mg once weekly is more efficacious than placebo in increasing or maintaining total proximal femur, femoral neck, and trochanter BMD after 1 year of treatment in women who are 0.5-5 years postmenopausal
To assess the general safety of 35-mg risedronate administered once weekly.

Enrollment

260 patients

Sex

Female

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

Main Inclusion/Exclusion criteria are listed hereafter:

Inclusion criteria:

Be postmenopausal for 0.5-5 years.Menopause is defined as 12 months without menses, based on medical history. Subjects who are post-menopausal secondary to bilateral oophorectomy must have serum FSH >40 mIU/mL and estradiol <20 pg/mL.
Subjects with 3 contiguous lumbar spine vertebral bodies (L1-L4) without fracture or degenerative disease.
Lumbar spine BMD mean value > 0.772g/cm2 (Hologic) or >0.880 g/cm2 (Lunar).

Exclusion criteria :

Subjects with adequate lumbar spine BMD but osteoporotic by total proximal femur BMD (<0.637 g/cm2 [Hologic]) or <0.694 g/cm2 [Lunar]) as determined by dual-energy x-ray absorptiometry (DXA)