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

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT01065779

Acronym / sponsor ID

0217A-267

Conditions

Osteoporosis

Study type

Observational

Recruitment status

Completed

Enrolment

880 participants (actual)

Lead sponsor

Organon and CoIndustry (pharma, biotech, devices)

Study start

Mar 2006

Primary completion

Jul 2010 (actual)

Study completion

Jul 2010 (actual)

First posted

9 Feb 2010 (estimated)

Results

Posted 13 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model

Other

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Study population

Patients with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Number of Participants With Serious Adverse Events

   Time frame: Up to ~ 16 weeks and 14 days after treatment discontinuation

   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

2. Number of Participants With Unexpected Adverse Events

   Time frame: Up to ~ 16 weeks and 14 days after treatment discontinuation

   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.

3. Number of Participants With Non-Serious AEs

   Time frame: Up to ~ 16 weeks and 14 days after treatment discontinuation

   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.

4. Number of Participants With Improved, Unchanged, or Worsened Disease

   Time frame: Baseline and end of Treatment (Up to ~ 16 weeks)

   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".

5. Change From Baseline in Serum 25-hydroxyvitamin D at End of Treatment

   Time frame: Baseline and End of Treatment (Up to ~ 16 weeks)

   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.

6. Change From Baseline in Serum Osteocalcin at End of Treatment

   Time frame: Baseline and End of Treatment (Up to ~ 16 weeks)

   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.

7. Change From Baseline in Urine Deoxypyridinoline at End of Treatment

   Time frame: Baseline and End of Treatment (Up to ~ 16 weeks)

   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.

8. Change From Baseline in Alkaline Phosphatase at End of Treatment

   Time frame: Baseline and End of Treatment (Up to ~ 16 weeks)

   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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Osteoporosis

• RecruitingObservational study

  A Clinical Study to Collect Real-wordt Data on Safety and Clinical Performance of the VCFix Spinal System for Treatment of Vertebral Compression Fractures of (Suspected) Osteoporotic Origin.

  Vertebra Compression Fracture

• Active, not recruitingObservational study

  The Impact of Osteosarcopenia on Falls, Kinesiophobia, and Quality of Life in Postmenopausal Women

  Osteosarcopenia, Sarcopenia

• Active, not recruitingPhase 2

  TCM Formula vs. HMB in Pre-Frail Elders: Muscle Strength and Bone Status

  Pre-Frailty, Sarcopenia

• Not yet recruitingPhase 4

  Romosozumab and Denosumab Combination Therapy for Osteoporosis

  Postmenopausal Osteoporosis

• RecruitingObservational study

  Assessment and Comparison of Osteoporosis Risk Factors After Stroke

  Stroke, Osteoporosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.