A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)
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
2 other identifiers
interventional
515
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2008
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 4, 2008
CompletedFirst Posted
Study publicly available on registry
June 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
August 15, 2011
CompletedMay 9, 2024
February 1, 2022
2.1 years
June 4, 2008
July 20, 2011
April 17, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio
Baseline and Week 26
Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase
Baseline and Week 26
Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52
Week 52
Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density
Baseline and Week 52
Falls Per Participant
Up to Week 52
- +2 more secondary outcomes
Study Arms (2)
FOSAVANCE 5600
EXPERIMENTALalendronate sodium (+) cholecalciferol
Referred-Care Model
OTHERUsual treatment for osteoporosis chosen and prescribed by patients' own physicians.
Interventions
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).
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).
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).
Eligibility Criteria
You may qualify if:
- Female
- 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
You may not qualify if:
- Unable to stand or sit upright for at least 30 minutes
- Has a bone disorder other than osteoporosis
- Contraindication to the use of FOSAVANCE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
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.
PMID: 21479913BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2008
First Posted
June 6, 2008
Study Start
June 1, 2008
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
May 9, 2024
Results First Posted
August 15, 2011
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share