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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
Must not have
Has had an osteoporotic fracture within the last 5 years
Females who are pregnant or planning pregnancy within the next year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 45 and 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a bone fracture due to osteoporosis in the last 5 years.
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I am not pregnant nor planning to become pregnant in the next year.
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I have a history of bone metabolism disorders.
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I am currently taking glucocorticoids.
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I have been treated for osteoporosis with medication.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility - Adherence
Feasibility - Attrition
Feasibility - Recruitment
Secondary study objectives
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
4%
Total serious cardiovascular adverse events
4%
Persistently elevated HCT >= 54%
2%
Elevated AUA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Lower-range T
Higher-range T

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.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
805 Previous Clinical Trials
883,992 Total Patients Enrolled
4 Trials studying Osteoporosis
427 Patients Enrolled for Osteoporosis
Leigh Gabel, PhDPrincipal InvestigatorUniversity of Calgary
~17 spots leftby Jun 2025
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