Studying Patient Experiences in Osteoporosis Clinical Trials

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05937945
Collaborator
(none)
500
1
24
20.8

Study Details

Study Description

Brief Summary

Clinical trials for osteoporosis are designed to assess the safety and effectiveness of novel osteoporosis treatments. These trials play a crucial role in establishing whether these new treatments outperform existing options and provide substantial evidence to support their adoption within the wider population.

The primary aim of this particular study is to investigate the experiences of individuals diagnosed with osteoporosis who participate in a distinct clinical trial involving a medical intervention. The focus will be on closely monitoring the rates of trial completion and withdrawal among these participants.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Uncovering Osteoporosis Clinical Trials: Firsthand Patient Insights Into Clinical Trial Experiences
    Anticipated Study Start Date :
    Jul 1, 2024
    Anticipated Primary Completion Date :
    Jul 1, 2025
    Anticipated Study Completion Date :
    Jul 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients who decide to join in an osteoporosis clinical trial [3 months]

    2. Rate of patients who remain in osteoporosis clinical trial to trial completion [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patient has been diagnosed with osteoporosis

    • Patient has self-identified as planning to enroll in an observational clinical trial

    • Patient is a minimum of 18 years or older

    Exclusion Criteria:
    • Pregnant or nursing patients

    • Inability to perform regular electronic reporting

    • Patient does not understand, sign, and return consent form

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Power Life Sciences San Francisco California United States 94107

    Sponsors and Collaborators

    • Power Life Sciences Inc.

    Investigators

    • Study Director: Michael B Gill, Power Life Sciences Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Power Life Sciences Inc.
    ClinicalTrials.gov Identifier:
    NCT05937945
    Other Study ID Numbers:
    • 83312301
    First Posted:
    Jul 10, 2023
    Last Update Posted:
    Jul 10, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Power Life Sciences Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 10, 2023