Status:
COMPLETED
Risedronate in Postmenopausal Women With Low Bone Density
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Procter and Gamble
Conditions:
OSTEOPOROSIS, POSTMENOPAUSAL
Eligibility:
FEMALE
65-80 years
Phase:
PHASE2
Brief Summary
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 mont...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00351091
Start Date
November 1 2002
End Date
June 1 2003
Last Update
February 17 2012
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