Studying Patient Experiences in Osteoporosis Clinical Trials

NCT05937945 | Not Yet Recruiting

• 1 other identifier: 83312301
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

osteoporosis

Outcome Measures

Primary Outcomes (2)

• Number of patients who decide to join in an osteoporosis clinical trial

  3 months

• Rate of patients who remain in osteoporosis clinical trial to trial completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Osteoporosis patients who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.

You may qualify if:

• 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

You may not qualify if:

• Pregnant or nursing patients
• Inability to perform regular electronic reporting
• Patient does not understand, sign, and return consent form

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• Liu C, Liu N, Xia Y, Zhao Z, Xiao T, Li H. Osteoporosis and sarcopenia-related traits: A bi-directional Mendelian randomization study. Front Endocrinol (Lausanne). 2022 Sep 14;13:975647. doi: 10.3389/fendo.2022.975647. eCollection 2022.

  PMID: 36187130 BACKGROUND

• Bell A, Kendler DL, Khan AA, Shapiro C M M, Morisset A, Leung JP, Reiner M, Colgan SM, Slatkovska L, Packalen M. A retrospective observational study of osteoporosis management after a fragility fracture in primary care. Arch Osteoporos. 2022 May 6;17(1):75. doi: 10.1007/s11657-022-01110-z.

  PMID: 35513573 BACKGROUND

• Amer M, Noor S, Kashif SM, Nazir SUR, Ghazanfar T, Yousaf S. Evaluation of Disease Related Knowledge in Patients of Osteoporosis: An Observational Study. Altern Ther Health Med. 2021 Jun;27(S1):97-103.

  PMID: 32663187 BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 10, 2023
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 10, 2023

Record last verified: 2023-06

Locations

US (1)