Risedronate in Postmenopausal Women With Low Bone Density

Sanofi

Status and phase

Completed

Phase 2

Conditions

OSTEOPOROSIS, POSTMENOPAUSAL

Treatments

Drug: RISEDRONATE

Study type

Interventional

Funder types

Industry

Identifiers

NCT00351091

HMR4003B_2501

Details and patient eligibility

About

The primary objective of this pilot study is to estimate the percent change from baseline at Week 4, Month 6 in NTX bone turnover marker for a monthly 150mg dose of risedronate administered for 6 months and a loading dose regimen of risedronate over a 6 month treatment period both compared to a 5 mg daily dose of risedronate for 6 months

The secondary objectives are :

To estimate the percent change from baseline at specified visits other than Week 4, Month 6 in NTX for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate.
To estimate the percent change from baseline at all specified visits in serum CTX and bone specific alkaline phosphatase for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily of risedronate.
To estimate the percent change from baseline at Month 6 in lumbar spine BMD for the monthly 150 mg dose of risedronate administered for 6 months and the loading dose regimen of risedronate over a 6 month treatment period both compared to the 5 mg daily dose of risedronate.
To evaluate the safety of the risedronate 150 mg monthly and the loading dose regimen.

Enrollment

150 patients

Sex

Female

Ages

65 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

ambulatory women,postmenopausal >= 5 years
have lumbar spine baseline BMD within the following criterion :
- Hologic: <= 0.827 g/cm2 or
- Lunar: <= 0.942 g/cm2 or
- Norland: <= 0.768 g/cm2
be in general good health as determined by medical history, physical examination and laboratory tests

Exclusion criteria

serum 25-OH vitamin D level <= 12 ng/ml
history of osteomalacia
history of active hyperparathyroidism or hyperthyroidism
hypocalcemia or hypercalcemia from any cause
depot injection >10,000 IU Vitamin D in the past 9 months prior to starting the investigational product
use of Vitamin D supplementation within 3 months prior to starting the investigational product
use of any of the following medications within a specified number of months prior to starting the investigational product :
- any bisphosphonate.
- use of any fluoride with the exception of fluoride use for oral hygiene
- strontium
- other bone active agents
- subcutaneous estrogen implant
- oral or parenteral glucocorticoids
- anabolic steroids
- estrogen or estrogen-related drugs, except for low dose vaginal creams
- progestogen
- calcitonin, calcitriol, or calcifediol
any allergic or abnormal reaction to bisphosphonates
creatinine clearance < 30 ml/min