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

Phase 3

Completed

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

• Registration Number: NCT00692913
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-04
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-06
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-07-20
• Results First Submitted QC: 2011-07-20
• Results First Posted: 2011-08-15
• Status Verified: 2022-02
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 515

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOSAVANCE 5600	FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol)	alendronate sodium (+) cholecalciferol
Referred-Care Model	Referred-Care Model	Usual treatment for osteoporosis chosen and prescribed by patients' own physicians.
FOSAVANCE 5600	Calcium Supplement 500 mg	alendronate sodium (+) cholecalciferol

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Falls Per Participant	Up to Week 52	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.
Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio	Baseline and Week 52	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.
Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio	Baseline and Week 26	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.
Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase	Baseline and Week 26	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.
Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density	Baseline and Week 52	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.
Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52	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.
Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase	Baseline and Week 52	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.