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Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)

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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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
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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

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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.


Eligibility Criteria
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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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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