FOSAMAX PLUS and FOSAMAX PLUS D Re-examination Study (0217A-267 AM3)(COMPLETED) - Full Text View

Purpose

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).

Condition	Intervention
Osteoporosis	Drug: FOSAMAX PLUS Drug: FOSAMAX PLUS D

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of FOSAMAX PLUS and FOSAMAX PLUS D in Usual Practice

Resource links provided by NLM:

MedlinePlus related topics: Osteoporosis

Drug Information available for: Alendronate sodium

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

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.

Enrollment:	880
Study Start Date:	March 2006
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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).	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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065779

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT01065779 History of Changes
Other Study ID Numbers:	MK-0217A-267, 2010_007
Study First Received:	February 8, 2010
Results First Received:	June 21, 2011
Last Updated:	August 9, 2011
Health Authority:	Korea: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013