OsteoporosisNCT05937945
Studying Patient Experiences in Osteoporosis Clinical Trials
An observational study of Osteoporosis, run by Power Life Sciences Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoporosis
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2024to Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Osteoporosis patients who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.
Who may be able to join
- 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
Who cannot join
- Pregnant or nursing patients
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
Trial locations and contacts
1 site in 1 country.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Uncovering Osteoporosis Clinical Trials: Firsthand Patient Insights Into Clinical Trial Experiences
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
- Medical subject headings
- Osteoporosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who decide to join in an osteoporosis clinical trial
Measured: 3 months
Rate of patients who remain in osteoporosis clinical trial to trial completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study startJul 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937945
- Sponsor's protocol ID
- 83312301
- Status last verified
- Jun 2023
- First submitted
- 30 Jun 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36187130Bell 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.
PubMed 35513573Amer 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.
PubMed 32663187
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncovering Osteoporosis Clinical Trials: Firsthand Patient Insights Into Clinical Trial Experiences
- ClinicalTrials.gov ID
- NCT05937945
- Acronym / sponsor ID
- 83312301
- Conditions
- Osteoporosis
- Keywords
- osteoporosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Osteoporosis patients who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant or nursing patients
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who decide to join in an osteoporosis clinical trial
Time frame: 3 months
Rate of patients who remain in osteoporosis clinical trial to trial completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Background: PubMed 36187130Liu 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.
- Background: PubMed 35513573Bell 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.
- Background: PubMed 32663187Amer 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.
- Individual participant dataSharing planned: Undecided
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.
Michael B Gill study director
Power Life Sciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoporosis, run by Power Life Sciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who decide to join in an osteoporosis clinical trial (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05937945, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.