Clinical trial NCT00692913: A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-06-06
Enrollment: 515
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26
timeFrame: Week 26
Secondary outcomes:
measure: Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
timeFrame: Baseline and Week 26
measure: Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase
timeFrame: Baseline and Week 26
measure: Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52
timeFrame: Week 52
measure: Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density
timeFrame: Baseline and Week 52
measure: Falls Per Participant
timeFrame: Up to Week 52
measure: Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
timeFrame: Baseline and Week 52
measure: Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase
timeFrame: Baseline and Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.