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

Study Overview
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Brief Summary
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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
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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

Conditions
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Osteoporosis

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FOSAVANCE 5600<br>alendronate sodium (+) cholecalciferol | Drug: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)<br>* FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).<br>Dietary Supplement: Calcium Supplement 500 mg<br>* Calcium supplied locally by the investigator (containing 500 mg calcium supplement) daily for 52 weeks (unless the patient's dietary intake of calcium exceeds 1000 mg per day).<br>|
| Other: Referred-Care Model<br>Usual treatment for osteoporosis chosen and prescribed by patients' own physicians. | Other: Referred-Care Model<br>* Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at 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. | Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio | N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio (NTx) is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. | Baseline and Week 26 | 
| Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase | Bone-Specific Alkaline Phosphatase (BSAP) is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 26/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. | Baseline and Week 26 | 
| Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52 | Percentage of participants with serum levels of 25-hydroxyvitamin D below 20 ng/mL after 52 weeks of treatment (6 month extension study) with FOSAVANCE 5600 once weekly versus Referred-Care in postmenopausal women with osteoporosis and at increased risk of falls. | Week 52 | 
| Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density | Bone Mineral Density (BMD) as measured by Dual Energy X-Ray Absorptiometry (DEXA) and measured in g/cm^2 was obtained at baseline (visit 1) and Week 52 (visit 13) or at early study discontinuation visit. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent change from baseline, the greater the response to therapy. | Baseline and Week 52 | 
| Falls Per Participant | Number of falls per participant was measured. The fall event rate during the study period was defined as the number of adjudicated falls during the study period divided by the total patient-years in the study. Each participant was to be in the study for approximately one year. In order to guide and standardize all procedures during the fall adjudication process, a Standard Operating Procedure for Fall Adjudication was created by the SPONSOR and served as a guideline to standardize operational procedures for fall adjudication. | Up to Week 52 | 
| Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio | NTx is a urine biochemical marker of bone resorption and measured in nanomoles (nmol) Bone Collagen Equivalents (BCE)/millimoles (mmol) creatinine. The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. | Baseline and Week 52 | 
| Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase | BSAP is a serum biochemical marker of bone formation and measured in micrograms/Liter (mcg/L). The percent change was calculated as: [100 * ((Week 52/Baseline)-1)]. The greater the percent decrease from baseline, the greater the response to therapy. | Baseline and Week 52 |