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FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01065779
First received: February 8, 2010
Last updated: August 1, 2014
Last verified: August 2014

February 8, 2010
August 1, 2014
March 2006
July 2010   (final data collection date for primary outcome measure)
  • Number of Participants With Serious Adverse Events [ Time Frame: Up to ~ 16 weeks and 14 days after treatment discontinuation ] [ Designated as safety issue: Yes ]

    Number of participants that experienced Serious Adverse events (SAE). There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators.

    SAEs were considered serious if the event resulted in:

    • death or was life-threatening
    • prolonged an existing inpatient hospitalization
    • a persistent or significant disability/ incapacity
    • a congenital anomaly/ birth defect
    • a significant medical situation, other important medical event based upon appropriate medical judgment of the investigator
  • Number of Participants With Unexpected Adverse Events [ Time Frame: Up to ~ 16 weeks and 14 days after treatment discontinuation ] [ Designated as safety issue: Yes ]
    Number of participants that experienced unexpected Adverse Events (AEs) regardless of whether or not the AE was considered related to the use of the product. There was no required routine visit scheduled for AE assessment. An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE.
  • Number of Participants With Non-Serious AEs [ Time Frame: Up to ~ 16 weeks and 14 days after treatment discontinuation ] [ Designated as safety issue: Yes ]
    An AE was defined as any unfavorable & unintended change in the structure, function, or chemistry of the body temporally associated with the use of the product, whether or not considered related to the use of the product. Any worsening (any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the product, was also considered an AE. There was no required routine visit scheduled for AE assessment. AEs were collected through participant self-reporting and assessed by investigators.
  • Number of Participants With Improved, Unchanged, or Worsened Disease [ Time Frame: Baseline and end of Treatment (Up to ~ 16 weeks) ] [ Designated as safety issue: No ]
    Evaluation of disease improvement was conducted in 3 categories of "improved", "unchanged", or "worsened". Changes in biochemical markers and vitamin D levels were reviewed before (baseline) and after treatment using statistical analyses to determine disease status, which was reported as either "improved", "unchanged", or "worsened".
  • Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment [ Time Frame: Baseline and End of Treatment (Up to ~ 16 weeks) ] [ Designated as safety issue: No ]
    For efficacy evaluation, changes in Serum 25-hydroxyvitamin D were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.
  • Change From Baseline in Serum Osteocalcin at End of Treatment [ Time Frame: Baseline and End of Treatment (Up to ~ 16 weeks) ] [ Designated as safety issue: No ]
    For efficacy evaluation, changes in Serum Osteocalcin were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.
  • Change From Baseline in Urine Deoxypyridinoline at End of Treatment [ Time Frame: Baseline and End of Treatment (Up to ~ 16 weeks) ] [ Designated as safety issue: No ]
    For efficacy evaluation, changes in Serum Deoxypyridinoline were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.
  • Change From Baseline in Alkaline Phosphatase at End of Treatment [ Time Frame: Baseline and End of Treatment (Up to ~ 16 weeks) ] [ Designated as safety issue: No ]
    For efficacy evaluation, changes in Serum Alkaline Phosphatase were evaluated before study drug administration and at end of study drug treatment. Change was calculated as the later time point (at ~16 weeks) minus the earlier time point (baseline). The Last Observation Carried Forward (LOCF) method was used. That is, the last observed non-missing value was used to fill in missing values at the later point in the study.
  • Percentage of patients with clinical and laboratory adverse reactions [ Time Frame: Up to 14 days after treatment discontinuation ] [ Designated as safety issue: Yes ]
  • Mean change of serum 25-hydroxyvitamin D and biochemical marker (serum osteocalcin, urine deoxypyridinoline and alkaline phosphatase) from baseline to treatment ; overall efficacy evaluation by investigator (improved, unchanged or worsened) [ Time Frame: 4 weeks and 12 weeks after first treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01065779 on ClinicalTrials.gov Archive Site
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FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267)
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of FOSAMAX PLUS and FOSAMAX PLUS D in Usual Practice

This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of FOSAMAX PLUS / FOSAMAX PLUS D through collecting the safety information according to the Re-examination Regulation for New Drugs.

Note: FOSAMAX PLUS D is known as FOSAMAX PLUS in several markets. FOSAMAX PLUS (70 mg/2800 IU) and FOSAMAX PLUS D (70 mg/5600 IU).

Not Provided
Observational
Time Perspective: Prospective
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Probability Sample

Patients with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D

Osteoporosis
  • Drug: FOSAMAX PLUS
    Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg alendronate/2800 International Units (IU) Vitamin D). One tablet taken once weekly.
  • Drug: FOSAMAX PLUS D
    Patients with Osteoporosis treated with FOSAMAX PLUS D (70 mg alendronate/5600 IU Vitamin D). One tablet taken once weekly.
FOSAMAX PLUS or FOSAMAX PLUS D
Patients with Osteoporosis treated with FOSAMAX PLUS (70 mg/2800 IU) or FOSAMAX PLUS D (70 mg/5600 IU).
Interventions:
  • Drug: FOSAMAX PLUS
  • Drug: FOSAMAX PLUS D
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
880
July 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants who are treated with FOSAMAX PLUS / FOSAMAX PLUS D within label for the first time

Exclusion Criteria:

  • Participants who have a contraindication to FOSAMAX PLUS / FOSAMAX PLUS D according to the current local label
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01065779
0217A-267, 2010_007
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

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