Who is sponsoring NCT00692913?

NCT00692913 is sponsored by Organon and Co.

What condition does NCT00692913 study?

NCT00692913 studies Osteoporosis.

What drugs are being tested in NCT00692913?

Interventions: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol), Calcium Supplement 500 mg, Referred-Care Model.

What is the status of NCT00692913?

NCT00692913 is currently COMPLETED.

Last reviewed 2024-04-17 · How we verify

A Phase III (Phase V Program), Open-Label, Randomized, Referred-Care-Controlled, Clinical Trial to Evaluate the Efficacy and Safety of MK -0217A/Alendronate Sodium-70 mg/Vitamin D3 5600 I.U. Combination Tablet on Vitamin D Inadequacy in the Treatment of Osteoporosis in Postmenopausal Women

NCT00692913 Phase 3 COMPLETED Results posted

A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.

Details

Lead sponsor	Organon and Co
Phase	Phase 3
Status	COMPLETED
Enrolment	515
Start date	2008-06
Completion	2010-07

Conditions

Osteoporosis

Interventions

FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)
Calcium Supplement 500 mg
Referred-Care Model

Primary outcomes

Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26 — Week 26
Percentage of participants with serum levels of 25-hydroxyvitamin D below 20 nanograms/milliliter (ng/mL) after 26 weeks of treatment with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls.