A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)

Condition(s) targeted: Osteoporosis

Intervention: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol) (Drug); Calcium Supplement 500 mg (Dietary Supplement); Referred-Care Model (Other)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.

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.

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26

Secondary outcome:

Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio

Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase

Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52

Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density

Falls Per Participant

Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio

Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female

- 65 years or older

- Diagnosed with osteoporosis (Bone Mineral Density (BMD) T-score <= -2. 5 at spine or

hip) or prior fragility fracture BMD T-score <=-1. 5 in at least one of the anatomic sites including lumbar spine, total hip, and femoral neck sites

- Postmenopausal

- Low levels of vitamin D as measured 25-hydroxyvitamin D

- Has fallen at least once within the past 12 months

Exclusion Criteria:

- Unable to stand or sit upright for at least 30 minutes

- Has a bone disorder other than osteoporosis

- Contraindication to the use of FOSAVANCE

Related publications:

Ralston SH, Binkley N, Boonen S, Kiel DP, Reginster JY, Roux C, Chen L, Rosenberg E, Santora A; FOCUS-D (FOSAVANCE vs. Standard Care-Use and Study of Vitamin D) Trial. Randomized trial of alendronate plus vitamin D3 versus standard care in osteoporotic postmenopausal women with vitamin D insufficiency. Calcif Tissue Int. 2011 Jun;88(6):485-94. doi: 10.1007/s00223-011-9482-4. Epub 2011 Apr 11.

Starting date: June 2008
Last updated: July 21, 2015