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Trial · NCT01652690

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Participants Receiving All Prescriptions and Injections of Denosumab From the Initial Prescribing Physician's Office24 monthsNumber of participants who received all injection(s), including baseline injection, from the initial prescribing site irrespective of total number of injections received on study.
PrimaryNumber of Participants Receiving an Individual Prescription and Injection of Denosumab From the Initial Prescribing Physician Office by Each Individual InjectionBaseline (day 1), and at Months 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)
PrimaryNumber of Participants Receiving All Prescriptions and Injections of DenosumabMonths 6, 12, 18 and 24 (corresponding to the first, second, third and fourth post-baseline injections respectively)Number of participants receiving all prescriptions and injections of denosumab whether or not the injections are given at the initial prescribing physician's office.
PrimaryNumber of Participants With a Referral by the Prescribing Physician to Other Health Care Providers for Continuation or Follow-up of Care24 months
PrimaryTypes of Health Care Providers Administering an Individual Injection of Denosumab at the Baseline InjectionBaseline (day 1)Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the baseline injection.
PrimaryTypes of Health Care Providers Administering Denosumab at the First Post-baseline InjectionMonth 6Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the first post-baseline injection.
PrimaryTypes of Health Care Providers Administering Denosumab at the Second Post-baseline InjectionMonth 12Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the second post-baseline injection.
PrimaryTypes of Health Care Providers Administering Denosumab at the Third Post-baseline InjectionMonth 18Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the third post-baseline injection.
PrimaryTypes of Health Care Providers Administering Denosumab at the Fourth Post-baseline InjectionMonth 24Types of health care providers administering an individual injection of denosumab inside or outside the initial prescribing office at the fourth post-baseline injection.
PrimaryNumber of Denosumab Post-baseline Injections Received by Each Participant24 months
PrimaryNumber of Participants Having Radiologic Bone AssessmentsPre-baseline (before first denosumab injection) and during the study (post-baseline)Number of participants having radiologic bone assessments pre-treatment with denosumab and during the study.
PrimaryNumber of Participants Having Osteoporosis Related Laboratory ExaminationsPre-baseline (before first denosumab injection) and post-baseline
Number of participants having osteoporosis related laboratory examinations pre-treatment with denosumab and during the study. Participants may not have been given denosumab injection when they attended each visit.
SecondaryNumber of Participants With Adverse Drug Reactions (ADRs) to Denosumab24 monthsAdverse events (AEs) that were considered related to denosumab as evaluated by the investigator were classified as adverse drug reactions (ADRs).
SecondaryNumber of Participants With Serious ADRs to Denosumab24 months
Serious adverse events that were considered related to denosumab were classified as serious adverse drug reactions (SADRs). A serious adverse event (SAE) is any AE that also: • is fatal • is life threatening (places the patient at immediate risk of death) • requires in-patient hospitalization or prolongation of existing hospitalization • results in persistent or significant disability/incapacity • is a congenital anomaly/birth defect • is an "other significant medical hazard" that does not meet any of the above criteria.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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