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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00351091
Other study ID # HMR4003B_2501
Secondary ID
Status Completed
Phase Phase 2
First received July 11, 2006
Last updated February 15, 2012
Start date November 2002
Est. completion date June 2003

Study information

Verified date February 2012
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date June 2003
Est. primary completion date June 2003
Accepts healthy volunteers No
Gender Female
Age group 65 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
RISEDRONATE


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Sanofi Procter and Gamble

Outcome

Type Measure Description Time frame Safety issue
Primary Urine NTX at week 4 of month 6
Secondary Urine NTX at other visits, serum CTX and bone specific alkaline phosphatase, lumbar spine BMD
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