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Behavioural Intervention

Strength Training for Osteoporosis (STOP-EM Trial)

N/A

Recruiting

Led By Leigh Gabel, PhD

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

45-60 years old

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 months

Awards & highlights

STOP-EM Trial Summary

This trial will assess if exercise can help improve bone health, muscle strength, and menopausal symptoms in peri- and early menopausal women.

Who is the study for?

This trial is for women aged 45-60 who are in peri- or early menopause, not currently doing resistance training, and have no recent severe fractures or conditions worsened by exercise. They shouldn't be pregnant nor planning pregnancy soon, without metabolic bone diseases, active steroid use, or low vitamin D/calcium levels.Check my eligibility

What is being tested?

The study tests if a high-intensity resistance training program over 9 months is practical for participants to follow. It will also look at the effects on bone health, muscle strength, and menopausal symptoms compared to a group that waits to start the program.See study design

What are the potential side effects?

While specific side effects aren't listed for this type of physical intervention, general risks may include muscle soreness, joint pain or injury from improper technique or overexertion during resistance training exercises.

STOP-EM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 45 and 60 years old.

STOP-EM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Feasibility - Adherence

Feasibility - Attrition

Feasibility - Recruitment

Secondary outcome measures

Aerobic Fitness

Balance

Biomarker of bone formation

+16 more

Side effects data

From 2010 Phase 2 trial • 167 Patients • NCT00112151

66%

Other noncardiovascular serious adverse events

13%

Other nonserious adverse events

11%

Persistently elevated PSA

Total serious cardiovascular adverse events

Persistently elevated HCT >= 54%

Elevated AUA

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Lower-range T

Higher-range T

STOP-EM Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExerciseExperimental Treatment1 Intervention

In-person, supervised resistance training program

Group II: ControlActive Control1 Intervention

Waitlist control group. Will be offered the exercise program following a 9-month wait.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor

792 Previous Clinical Trials

869,114 Total Patients Enrolled

4 Trials studying Osteoporosis

427 Patients Enrolled for Osteoporosis

Leigh Gabel, PhDPrincipal InvestigatorUniversity of Calgary

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of this medical experiment in terms of patient numbers?

"Affirmative. Records from clinicaltrials.gov demonstrate that this medical trial, which was originally published on November 1st 2023, is currently scouting for participants. A total of 40 patients must be recruited at one site in particular."

Answered by AI

Has enrollment for this experiment been opened to the public?

"Clinicaltrials.gov provides evidence that this study is actively searching for participants, with the original posting being on November 1st 2023 and the most recent update happening on November 27th 2023."

Answered by AI

Are senior citizens a part of the recruitment process for this research endeavor?

"According to the stated stipulations, individuals aged between 45 and 60 are eligible to enroll in this trial."

Answered by AI

What characteristics make an individual suitable for this experiment?

"This medical trial is seeking 40 participants aged 45-60 who suffer from osteoporosis and meet specific menopausal criteria such as peri- or early menopausal status, or are within 5 years of their last menses."

Answered by AI

What is the main goal that this investigation seeks to answer?

"This experiment, which is due to be concluded in 9 months, seeks to ascertain the adherence of patients. Secondary objectives include evaluating volumetric bone mineral density (BMD) through high-resolution peripheral quantitative computed tomography (HR-pQCT), assessing bone microarchitecture using HR-PQCT, and determining bone strength utilizing finite element analysis applied to HR-PQCT images."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Strength Training for Osteoporosis Prevention During Early Menopause

Leigh Gabel 2023. "Strength Training for Osteoporosis Prevention During Early Menopause". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05961371.

All > Premature Ovarian Failure > Menopause