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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01437111
First received: September 19, 2011
Last updated: August 11, 2014
Last verified: August 2014

September 19, 2011
August 11, 2014
October 2011
December 2012   (final data collection date for primary outcome measure)
Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study.
Proportion of participants with serum 25-hydroxyvitamin D greater than 50 ng/mL [ Time Frame: Week 26 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01437111 on ClinicalTrials.gov Archive Site
Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.
Percent change from baseline on bone resorption marker of serum Beta-Cross Laps (β-CTX) at Week 26 [ Time Frame: Baseline and Week 26 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)
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

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].

Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Osteoporosis
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
Experimental: Fosamax Plus
Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants
Intervention: Drug: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01437111
0217A-329
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP