Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01437111 |
Recruitment Status
:
Completed
First Posted
: September 20, 2011
Results First Posted
: January 22, 2014
Last Update Posted
: May 11, 2017
|
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Brief Summary:
This study will assess the effect of 26 weeks of once-weekly treatment with MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) on serum levels of 25-hydroxyvitamin D [25(OH)D].
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis | Drug: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 200 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase III (Phase IV Program) Open-Label, Multicenter Clinical Trial in Thailand to Study the Effect of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) for 6 Months on 25-Hydroxyvitamin D Levels in the Treatment of Osteoporosis in Postmenopausal Women and Men |
Actual Study Start Date : | October 26, 2011 |
Actual Primary Completion Date : | December 5, 2012 |
Actual Study Completion Date : | December 5, 2012 |
Arm | Intervention/treatment |
---|---|
Experimental: Fosamax Plus
Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants
|
Drug: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet
One combination tablet orally once a week
Other Name: Fosamax Plus 70/5600
|
Primary Outcome Measures
:
- Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 [ Time Frame: Week 26 ]Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study.
Secondary Outcome Measures
:
- Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 [ Time Frame: Baseline and Week 26 ]Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Man aged 50 or older, or a woman who is postmenopausal on day of signing informed consent or has been menopausal for at least one year
- Meets bone mineral density (BMD) criteria
- Agree to discontinue any osteoporosis drug treatment for duration of study
Exclusion Criteria:
- Any contraindication to alendronate and vitamin D
- Not ambulatory
- Has received treatment with any anabolic steroid agent within the past 12 months, systemic glucocorticoids, for more than 2 weeks in the past 6 months, current use of immunosuppressants, fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks within the past 3 months, treated with parathyroid hormone (PTH) for more than 2 weeks within the past 3 months, current use of chemotherapy or heparin, use of growth hormone for more than 2 weeks within the past 6 months, use of active hormonal vitamin D analogs in the past 2 months, current use of vitamin A >10,000 IU daily, current use of, lithium, or anti-convulsants including barbiturates, hydantoins, and carbamazepine, current use of calcium supplement in amount excess of 1500 mg daily, and/or current use of Vitamin D supplement
- History of malignancy <5 years, except adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer
- One or more of the following concomitant conditions: Upper gastrointestinal (GI) disorders not adequately controlled; myocardial infarction, unstable angina, stroke and revascularization condition within 3 months; malabsorption syndrome; primary or secondary hyperparathyroidism not adequately treated; thyroid disease not adequately controlled; severe renal insufficiency; uncontrolled genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, neurological, psychiatric, or pulmonary diseases; uncontrolled hypertension; new onset diabetes (within 3 months), poorly controlled hyperglycemia, or hypoglycemia for any cause; evidence for metabolic bone disease other than osteoporosis; abnormal indices of calcium metabolism; and/or active renal stone disease
- User of illicit recreational drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
- Heavy consumer of alcohol or alcohol containing products.
No Contacts or Locations Provided
Responsible Party: | Merck Sharp & Dohme Corp. |
ClinicalTrials.gov Identifier: | NCT01437111 History of Changes |
Other Study ID Numbers: |
0217A-329 |
First Posted: | September 20, 2011 Key Record Dates |
Results First Posted: | January 22, 2014 |
Last Update Posted: | May 11, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php |
Keywords provided by Merck Sharp & Dohme Corp.:
Osteoporosis Postmenopausal |
Additional relevant MeSH terms:
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases Vitamins Vitamin D |
Ergocalciferols Cholecalciferol Alendronate Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |