OsteopeniaNCT05060380
Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis
A study testing Exercise training in people with Osteopenia and Osteoporosis, run by University of Alabama at Birmingham.
Trial summary
The aim of the 2 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in individuals with low bone mass. Read more about this study
- Who is it for?
- Ages 55 to 70 years, women only
- Conditions the study is for
- Osteopenia, Osteoporosis, Postmenopausal Osteoporosis
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Dec 2028
- Phase
- Interventional
- 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 55 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- independent ambulatory
- diagnosed with low bone mass
Who cannot join
- uncontrolled hypertension
- secondary osteoporosis
- fragility fracture,
- clinical or laboratory evidence of hepatic
- renal disease,
- uncontrolled disorders of the parathyroid
Show all 13Show fewer
- thyroid glands,
- a history of cancer in the past 5 years,
- any structured resistance training within the previous year, and
- past therapy with any drug for osteoporosis,
- any current therapy for osteoporosis except zoledronic acid,
- inability to walk independently or
- any other medical conditions which could restrict the potential participants from full participation as decided by their physician.
About this study
The aim of the 2 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in individuals with low bone mass.
Read the detailed description
In 2008, medical cost of osteoporosis and osteoporosis-related fractures was estimated to be $22 billion. This is further expected to rise because of an increase of 20% in population with osteoporosis, amounting to 12 million adults over the age of 50 years, by 2020, out of which 80% will be postmenopausal women. Unfortunately, benefits due to pharmacological interventions have plateaued. Consequently, there is a critical need to identify complementary therapies to enhance the treatment of low bone mass in older adults. The aim of this study is to examine the feasibility of novel progressive muscle resistance exercise in postmenopausal women with low bone mass. Muscle will be assessed via imaging techniques and isokinetic dynamometer. Physical activity will be assessed via activity monitors. Blood will be collected to assess bone and muscle biomarkers. Balance will be assessed via clinical and biomechanical tests. Testing will be performed at 4 time points: baseline, 1 month, 3 month, and 6 months except imaging which will be done at the baseline and 6 months. The findings from this study will help us to understand the feasibility of resistive muscle exercise program in postmenopausal women with low bone mass.
- Conditions
- Osteopenia, Osteoporosis, Postmenopausal Osteoporosis, Sarcopenia
- Being tested
- Exercise training
- Keywords
- aging, bone, muscle, exercise
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis, Osteoporosis, Postmenopausal, Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise trainingOther
Progressive muscle resistive exercise will be performed by the experimental group only. Control group will maintain their normal level of daily activity.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training | Experimental | The exercise training group will receive progressive muscle resistive exercise, 10 sets of exercises for 2 times per week for a total of 6 months. Receives: Other: Exercise training |
| Control | No intervention | The control group will be asked to maintain their normal lifestyle and will be advised to continue their standard care of treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone biomarker
bone formation and resorption marker
Measured: baseline
Bone biomarker
bone formation and resorption marker
Measured: 1 month
Bone biomarker
bone formation and resorption marker
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Why it stopped: The study was never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals will be randomly assigned to exercise or no exercise group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harshvardhan Singh, PhD, University of Alabama at Birmingham
- Investigators
- HARSHVARDHAN SINGH, PT, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060380
- Sponsor's protocol ID
- 300004541
- Status last verified
- Jun 2026
- First submitted
- 28 Jul 2021
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Novel Resistance Exercise in Individuals With Osteoporosis
- ClinicalTrials.gov ID
- NCT05060380
- Acronym / sponsor ID
- 300004541
- Conditions
- Osteopenia, Osteoporosis, Postmenopausal Osteoporosis, Sarcopenia
- Keywords
- aging, bone, muscle, exercise
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 29 Sep 2021 (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.
The aim of the 2 month randomized controlled trial is to investigate the feasibility of a novel progressive muscle resistance exercise in individuals with low bone mass.
Detailed description
In 2008, medical cost of osteoporosis and osteoporosis-related fractures was estimated to be $22 billion. This is further expected to rise because of an increase of 20% in population with osteoporosis, amounting to 12 million adults over the age of 50 years, by 2020, out of which 80% will be postmenopausal women. Unfortunately, benefits due to pharmacological interventions have plateaued. Consequently, there is a critical need to identify complementary therapies to enhance the treatment of low bone mass in older adults. The aim of this study is to examine the feasibility of novel progressive muscle resistance exercise in postmenopausal women with low bone mass. Muscle will be assessed via imaging techniques and isokinetic dynamometer. Physical activity will be assessed via activity monitors. Blood will be collected to assess bone and muscle biomarkers. Balance will be assessed via clinical and biomechanical tests. Testing will be performed at 4 time points: baseline, 1 month, 3 month, and 6 months except imaging which will be done at the baseline and 6 months. The findings from this study will help us to understand the feasibility of resistive muscle exercise program in postmenopausal women with low bone mass.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Individuals will be randomly assigned to exercise or no exercise group.
| Arm | Type | Receives |
|---|---|---|
| Exercise training | Experimental | Other: Exercise trainingThe exercise training group will receive progressive muscle resistive exercise, 10 sets of exercises for 2 times per week for a total of 6 months. |
| Control | No intervention | –The control group will be asked to maintain their normal lifestyle and will be advised to continue their standard care of treatment. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- independent ambulatory
- diagnosed with low bone mass
Key exclusion criteria (13 listed)
- uncontrolled hypertension
- secondary osteoporosis
- fragility fracture,
- clinical or laboratory evidence of hepatic
- renal disease,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingProgressive muscle resistive exercise will be performed by the experimental group only. Control group will maintain their normal level of daily activity. | Other | Exercise training |
Primary outcome
Bone biomarker
Time frame: baseline
bone formation and resorption marker
Bone biomarker
Time frame: 1 month
bone formation and resorption marker
Bone biomarker
Time frame: 2 month
bone formation and resorption marker
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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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.
HARSHVARDHAN SINGH, PT, PhD principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Osteopenia and Osteoporosis, run by University of Alabama at Birmingham.
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 2 inclusion and 13 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: withdrawn, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone biomarker (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.