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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:
ClinicalTrials.gov Identifier:
NCT01437111
First Posted: September 20, 2011
Last Update Posted: May 11, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
September 19, 2011
September 20, 2011
December 3, 2013
January 22, 2014
May 11, 2017
October 26, 2011
December 5, 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 ]
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 ]
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 ]
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 ]
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
Intervention Model: Single Group Assignment
Masking: None (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 5, 2012
December 5, 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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Thailand
 
NCT01437111
0217A-329
No
Not Provided
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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2017

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