OsteoporosisNCT05541432
Finding the Optimal Resistance Training Intensity For Your Bones
A study testing Supervised strength training (group 1), Supervised strength training (group 2) and Home exercise in people with Osteoporosis and Osteopenia, run by University of Waterloo at 3 sites in Canada.
Trial summary
Osteoporosis is a bone disease that can result in fractures, disability and an increased risk of premature death. Exercise is recommended for fall and fracture prevention, but health care professionals often recommend walking or lower intensity community exercise classes, which may not be effective for building bone. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Osteoporosis, Osteopenia
- What is being tested?
- Supervised strength training (group 1), Supervised strength training (group 2) and Home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 3 sitesCanada
- Study dates
- 13 Sep 2022to 28 Feb 2026
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50 or over
- Has received 2 vaccines for COVID-19
- Has femoral neck, total hip, or lumbar spine BMD T-score of ≤ -1, OR has been or have a FRAX probability of fracture of greater than or equal to 20% for major osteoporotic fracture or 3% or greater for hip fracture.*
- Individuals at high risk of fracture (i.e., risk in next 10 years is >20% according to FRAX) should be offered medication for osteoporosis. We will only include individuals at high risk of fracture who have declined medication or who had been on osteoporosis medication and decided to cease taking it in the appropriate timeline (as outlined by PI's and Physician).
- Willing to participate in 2x weekly exercise sessions
- Self-reported as postmenopausal for ≥ 2 years, OR postmenopausal stats confirmed via blood test (female participants only)
Who cannot join
- Is unable to communicate in English
- Has conditions affecting bone health
- Takes or has taken medications affecting bone in the last 12 months or longer (as determined by the research team)
- Has had a clinical or symptomatic spine fracture in the last 12 months, or a lower/upper limb fracture in the last 6 months
- Has had a joint replacement in the last 6 months
- Is receiving palliative care
Show all 13Show fewer
- Has major surgery planned in the next 12 months
- Has had cancer within the last 2 years (excluding non-melanoma skin cancer)
- Has planned travel time of greater than 6 weeks
- Has been diagnosed with dementia
- Is already participating in moderate- or high-intensity progressive resistance training ≥ twice weekly
- Weighs over 450 lbs
- Has contraindications to resistance training
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of Toronto
Markham
University of Saskatchewan
Saskatoon
University of Waterloo
Waterloo, Ontario
About this study
Official title: Finding the Optimal Resistance Training Intensity For Your Bones: A Randomized Controlled Trial (FORTIFY Bones)
Osteoporosis is a bone disease that can result in fractures, disability and an increased risk of premature death. Exercise is recommended for fall and fracture prevention, but health care professionals often recommend walking or lower intensity community exercise classes, which may not be effective for building bone. Further, individuals with osteoporosis are often told to avoid lifting or moving in certain ways, which creates fear and activity avoidance. Conversely, research suggests that to stimulate bone, you need higher loads on bone, with either higher intensity resistance training or impact exercise - the types of things people with low bone mass are told to avoid. Our study will examine different types of exercise intensity and how they translate to building bone in people with low bone mineral density (BMD).
Read the detailed description
The FORTIFY Bones study will compare the effect of supervised twice-weekly progressive resistance training (PRT) at moderate or high intensity for one year to a home posture and balance exercise program on lumbar spine bone mineral density (BMD), in individuals with low bone mass not taking osteoporosis medication. As secondary analyses, we will examine the differences between each resistance training intensity and home exercise, and between resistance training intensities on all outcomes. Participants will be randomized to one of three exercise programs to be completed twice weekly: posture and balance exercise program at home, in-person, supervised progressive resistance training at 70% of estimated 1 Repetition Maximum (1RM) intensity, or in-person, supervised progressive resistance training at an 85% estimated 1RM intensity. The study is a multi-centre trial that will take place at the University of Waterloo, Toronto General Hospital, and the University of Saskatchewan. The long-term goal of this study is to generate evidence to support decision-making on the type of exercises for people with osteoporosis.
- Conditions
- Osteoporosis, Osteopenia
- Being tested
- Supervised strength training (group 1), Supervised strength training (group 2), Home exercise
- Keywords
- Bone fracture, Strength training, Exercise, Bone mineral density, Muscle strength, Resistance training
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic, Fractures, Bone, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised strength training (group 1)Other
Participants in this arm will complete twice weekly resistance training. They will focus on form initially, and then be progressed to 3 sets of 10-12 repetitions at an intensity of ~70% of estimated 1 repetition maximum.
Supervised strength training (group 2)Other
Participants in this arm will complete twice weekly resistance training. They will focus on form initially, and then be progressed to 3 sets of ~4-6 repetitions at an intensity of 85% of estimated one repetition maximum, with a warm-up set of 8 repetitions at their estimated 70% estimated one repetition maximum to attempt to match the volume performed in the other resistance training group.
Home exerciseOther
Participants in this arm will complete twice-weekly upper and lower body exercises at home, focused on posture and balance. Participants will meet 1:1 with an exercise physiologist who will select and prescribe exercises. Participants will also be invited to attend twice monthly virtual exercise and education sessions.
| Study group | Role | What they receive |
|---|---|---|
| Home exercise | Active comparator | Home exercise program, with biweekly group virtual education and exercise classes. Receives: Other: Home exercise |
| Supervised strength training (group 1) | Experimental | In-person, supervised muscle strengthening exercises twice weekly at a specific intensity. Receives: Other: Supervised strength training (group 1) |
| Supervised strength training (group 2) | Experimental | In-person, supervised muscle strengthening exercises twice weekly at a specific intensity. Receives: Other: Supervised strength training (group 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar Spine bone mineral density (BMD)
Lumbar spine (L1-L4) bone mineral density measured via dual-energy X-ray Absorptiometry (DXA) scan.
Measured: Baseline and 12 months
Secondary outcomes (30)
Fractures
Composite outcome of new non-vertebral and vertebral fractures, and progression of existing vertebral fractures. We will report the number in each category separately. We will use a fracture questionnaire for non-vertebral fractures, and vertebral fractures that come to clinical attention. Participants will undergo a DXA scan for Vertebral Fracture Assessment (VFA) at baseline and the 12-months. A vertebral fracture will be defined as having a radiographic presence of ≥25% reduction in anterior, middle, or posterior vertebral height, verified by an experienced radiologist at University Health Network via the Genant visual semi-quantitative method. Baseline VFA will be assessed for vertebral fractures and compared to VFA at 12 months to ascertain if there has been progression of new fractures; progression will be defined as progression to a new Genant level or a change in height of at least 10%.
Measured: Over 12 months
Rate of falls per person per year
Participants will be emailed a falls calendar via a survey at the end of each month. Participants will be asked to immediately report any falls to research assistant and to exercise physiologist. Exercise physiologists will report any noted falls to their study coordinator immediately and additional follow-up documentation will be required. Rate of falls and number of people who experience one or more falls will be compared between groups.
Measured: Over 12 months
Number of people who experience one or more falls
Participants will be emailed a falls calendar via a survey at the end of each month. Participants will be asked to immediately report any falls to research assistant and to exercise physiologist. Exercise physiologists will report any noted falls to their study coordinator immediately and additional follow-up documentation will be required. Rate of falls and number of people who experience one or more falls will be compared between groups.
Measured: Over 12 months
Bone-free lean mass
Whole body fat- and bone-free lean mass will be derived from DXA scans.
Measured: Baseline and 12 months
Appendicular lean mass
We will calculate appendicular lean mass (kg) and its index (kg/m^2) from appendicular bone-free lean mass and height (cm).
Measured: Baseline and 12 months
Height
Height will be a proxy measure of posture.
Measured: Baseline and 12 months
Occiput-to-wall distance
Occiput-to-wall distance will be a proxy measure of posture.
Measured: Baseline and 12 months
Knee extension peak torque
We will assess isometric knee extension peak torque using a knee extension test with a dynamometer.
Measured: Baseline, 6 months, and 12 months
30 Second Chair Stand Test.
We will use the 30 Second Chair Stand Test.
Measured: Baseline, 6 months, and 12 months
Four Square Step Test
We will use the Four Square Step Test to assess lower extremity muscle power and dynamic balance during functional tasks.
Measured: Baseline, 6 months, and 12 months
Grip Strength
We will assess grip strength of the non-dominant arm using a hand dynamometer.
Measured: Baseline, 6 months, and 12 months
10 Metre Walk Test.
We will assess gait speed using the 10 Metre Walk Test.
Measured: Baseline, 6 months, and 12 months
6 Minute Walk Test.
We will assess endurance using the 6 Minute Walk Test.
Measured: Baseline, 6 months, and 12 months
Osteoporosis-specific quality of life (QUALEFFO-41)
We will use the QUALEFFO-41 as an osteoporosis specific measure of health-related quality of life.
Measured: Baseline, 6 months, and 12 months
Quality of life (EQ5D5L)
We will use the EQ5D5L measure as a generic health-related quality of life measure.
Measured: Baseline, 6 months, and 12 months
Serious adverse events
We will ask participants to report adverse events, using Health Canada definitions. We will report all serious and non-serious adverse events and identify those attributable to intervention. Safety outcomes will include all falls, fractures, and serious and non-serious adverse events. Any fractures or falls that are attributable to intervention will be considered under both fall or fracture outcomes, and harms.
Measured: Over 12 months
Non-serious adverse events
We will ask participants to report adverse events, using Health Canada definitions. We will report all serious and non-serious adverse events and identify those attributable to intervention. Safety outcomes will include all falls, fractures, and serious and non-serious adverse events. Any fractures or falls that are attributable to intervention will be considered under both fall or fracture outcomes, and harms.
Measured: Over 12 months
Glucose concentration
We will be taking a fasted blood sample from participants to measure plasma glucose concentrations using biochemical assay. Blood samples will only be collected from participants at the University of Waterloo site.
Measured: Baseline and 6 months
Insulin concentration
We will be taking a fasted blood sample from participants to measure serum insulin concentrations using radioimmunoassay. Blood samples will only be collected from participants at the University of Waterloo site.
Measured: Baseline and 6 months
Pro/anti-inflammatory markers
We will be taking a fasted blood sample from participants to measure plasma pro- and anti-inflammatory markers using a multiplex kit. Blood samples will only be collected from participants at the University of Waterloo site.
Measured: Baseline and 6 months
Oxidative stress markers/antioxidant status (including oxygen radical absorbance capacity (ORAC) assay, protein carbonyls, glutathione peroxidase activity, thioredoxin, malondialdehyde)
We will be taking a fasted blood sample from participants to measure antioxidant status and markers of oxidative stress using commercially available assays. Blood samples will only be collected from participants at the University of Waterloo site.
Measured: Baseline and 6 months
peptides synthesized and released by myocytes in muscle tissue
We will be taking fasting blood samples from participants to measure peptides synthesized and released by myocytes in muscle tissue via the Luminex Performance Assay. Blood samples will only be collected from participants at the University of Waterloo site.
Measured: Baseline and 6 months
Total Hip BMD
Bone mineral density of the hip measured via DXA scans
Measured: Baseline and 12 months
Femoral Neck BMD
Bone mineral density of the femoral neck measured via DXA scans
Measured: Baseline and 12 months
Trabecular Bone Score
Trabecular bone score (TBS) will be calculated using TBS iNsight software. A high TBS value indicates high quality boner structure, whereas a low TBS value demonstrates a lower quality structure. The TBS index ranges from 0.9 - 1.6.
Measured: Baseline and 12 months
Hip Geometry
We will use the DXA scanner's hip structural analysis feature to calculate estimates of hip geometry from proximal femur scans.
Measured: Baseline and 12 months
Health Service Use
We will assess direct medical resources (e.g., tests, medications, hospitalization, rehabilitation), direct non-medical resources (e.g., out of pocket expenses, transportation), indirect resources (e.g., iMTA Productivity Cost Questionnaire) and clinical events and management. We will assess resource use for incident falls, fractures or adverse events. Multiplying resources collected by jurisdictional unit costs in Canadian dollars will determine the total cost per exercise program.
Measured: Baseline, 6 months, and 12 months
Ratio of costs to QALY
We will calculate the ratio of incremental costs between the interventions, determined by trial resources, and clinical outcome (QALY) to achieve an incremental cost per life year gained outcome.
Measured: Baseline, 6 months, and 12 months
Willingness to pay
We will assess willingness to pay for various exercise models using a contingent valuation survey.
Measured: Baseline, 6 months, and 12 months
Body weight
Body weight in kg measured using scale
Measured: Baseline, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start13 Sep 2022
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1:1 ratio to one of three arms. Participants will perform exercise or control activities twice weekly for 12 months. Not all participants will start and end at the same time.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Saskatchewan, University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Lora Giangregorio, PhD, Principal investigator, University of Waterloo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541432
- Sponsor's protocol ID
- 41337
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2022
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D. Risk of mortality following clinical fractures. Osteoporos Int. 2000;11(7):556-61. doi: 10.1007/s001980070075.
PubMed 11069188Lindsay R, Silverman SL, Cooper C, Hanley DA, Barton I, Broy SB, Licata A, Benhamou L, Geusens P, Flowers K, Stracke H, Seeman E. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001 Jan 17;285(3):320-3. doi: 10.1001/jama.285.3.320.
PubMed 11176842Ioannidis G, Papaioannou A, Hopman WM, Akhtar-Danesh N, Anastassiades T, Pickard L, Kennedy CC, Prior JC, Olszynski WP, Davison KS, Goltzman D, Thabane L, Gafni A, Papadimitropoulos EA, Brown JP, Josse RG, Hanley DA, Adachi JD. Relation between fractures and mortality: results from the Canadian Multicentre Osteoporosis Study. CMAJ. 2009 Sep 1;181(5):265-71. doi: 10.1503/cmaj.081720. Epub 2009 Aug 4.
PubMed 19654194Hopkins RB, Burke N, Von Keyserlingk C, Leslie WD, Morin SN, Adachi JD, Papaioannou A, Bessette L, Brown JP, Pericleous L, Tarride J. The current economic burden of illness of osteoporosis in Canada. Osteoporos Int. 2016 Oct;27(10):3023-32. doi: 10.1007/s00198-016-3631-6. Epub 2016 May 11.
PubMed 27166680Howe TE, Shea B, Dawson LJ, Downie F, Murray A, Ross C, Harbour RT, Caldwell LM, Creed G. Exercise for preventing and treating osteoporosis in postmenopausal women. Cochrane Database Syst Rev. 2011 Jul 6;2011(7):CD000333. doi: 10.1002/14651858.CD000333.pub2.
PubMed 21735380El-Khoury F, Cassou B, Charles MA, Dargent-Molina P. The effect of fall prevention exercise programmes on fall induced injuries in community dwelling older adults: systematic review and meta-analysis of randomised controlled trials. BMJ. 2013 Oct 29;347:f6234. doi: 10.1136/bmj.f6234.
PubMed 24169944Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
PubMed 22972103Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent falls in older adults: an updated meta-analysis and best practice recommendations. N S W Public Health Bull. 2011 Jun;22(3-4):78-83. doi: 10.1071/NB10056.
PubMed 21632004Tricco AC, Thomas SM, Veroniki AA, Hamid JS, Cogo E, Strifler L, Khan PA, Robson R, Sibley KM, MacDonald H, Riva JJ, Thavorn K, Wilson C, Holroyd-Leduc J, Kerr GD, Feldman F, Majumdar SR, Jaglal SB, Hui W, Straus SE. Comparisons of Interventions for Preventing Falls in Older Adults: A Systematic Review and Meta-analysis. JAMA. 2017 Nov 7;318(17):1687-1699. doi: 10.1001/jama.2017.15006.
PubMed 29114830Duckham RL, Masud T, Taylor R, Kendrick D, Carpenter H, Iliffe S, Morris R, Gage H, Skelton DA, Dinan-Young S, Brooke-Wavell K. Randomised controlled trial of the effectiveness of community group and home-based falls prevention exercise programmes on bone health in older people: the ProAct65+ bone study. Age Ageing. 2015 Jul;44(4):573-9. doi: 10.1093/ageing/afv055. Epub 2015 Apr 23.
PubMed 25906791Nikander R, Gagnon C, Dunstan DW, Magliano DJ, Ebeling PR, Lu ZX, Zimmet PZ, Shaw JE, Daly RM. Frequent walking, but not total physical activity, is associated with increased fracture incidence: a 5-year follow-up of an Australian population-based prospective study (AusDiab). J Bone Miner Res. 2011 Jul;26(7):1638-47. doi: 10.1002/jbmr.363.
PubMed 21328475Rikkonen T, Salovaara K, Sirola J, Karkkainen M, Tuppurainen M, Jurvelin J, Honkanen R, Alhava E, Kroger H. Physical activity slows femoral bone loss but promotes wrist fractures in postmenopausal women: a 15-year follow-up of the OSTPRE study. J Bone Miner Res. 2010 Nov;25(11):2332-40. doi: 10.1002/jbmr.143.
PubMed 20533310Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2.
PubMed 30703272Costa AG, Wyman A, Siris ES, Watts NB, Silverman S, Saag KG, Roux C, Rossini M, Pfeilschifter J, Nieves JW, Netelenbos JC, March L, LaCroix AZ, Hooven FH, Greenspan SL, Gehlbach SH, Diez-Perez A, Cooper C, Compston JE, Chapurlat RD, Boonen S, Anderson FA Jr, Adachi JD, Adami S. When, where and how osteoporosis-associated fractures occur: an analysis from the Global Longitudinal Study of Osteoporosis in Women (GLOW). PLoS One. 2013 Dec 11;8(12):e83306. doi: 10.1371/journal.pone.0083306. eCollection 2013.
PubMed 24349484
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finding the Optimal Resistance Training Intensity For Your Bones: A Randomized Controlled Trial (FORTIFY Bones)
- ClinicalTrials.gov ID
- NCT05541432
- Acronym / sponsor ID
- 41337
- Conditions
- Osteoporosis, Osteopenia
- Keywords
- Bone fracture, Strength training, Exercise, Bone mineral density, Muscle strength, Resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), University of Saskatchewan, University Health Network, Toronto
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 15 Sep 2022 (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.
Osteoporosis is a bone disease that can result in fractures, disability and an increased risk of premature death. Exercise is recommended for fall and fracture prevention, but health care professionals often recommend walking or lower intensity community exercise classes, which may not be effective for building bone. Further, individuals with osteoporosis are often told to avoid lifting or moving in certain ways, which creates fear and activity avoidance. Conversely, research suggests that to stimulate bone, you need higher loads on bone, with either higher intensity resistance training or impact exercise - the types of things people with low bone mass are told to avoid. Our study will examine different types of exercise intensity and how they translate to building bone in people with low bone mineral density (BMD).
Detailed description
The FORTIFY Bones study will compare the effect of supervised twice-weekly progressive resistance training (PRT) at moderate or high intensity for one year to a home posture and balance exercise program on lumbar spine bone mineral density (BMD), in individuals with low bone mass not taking osteoporosis medication. As secondary analyses, we will examine the differences between each resistance training intensity and home exercise, and between resistance training intensities on all outcomes. Participants will be randomized to one of three exercise programs to be completed twice weekly: posture and balance exercise program at home, in-person, supervised progressive resistance training at 70% of estimated 1 Repetition Maximum (1RM) intensity, or in-person, supervised progressive resistance training at an 85% estimated 1RM intensity. The study is a multi-centre trial that will take place at the University of Waterloo, Toronto General Hospital, and the University of Saskatchewan. The long-term goal of this study is to generate evidence to support decision-making on the type of exercises for people with osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomized in a 1:1:1 ratio to one of three arms. Participants will perform exercise or control activities twice weekly for 12 months. Not all participants will start and end at the same time.
| Arm | Type | Receives |
|---|---|---|
| Home exercise | Active comparator | Other: Home exerciseHome exercise program, with biweekly group virtual education and exercise classes. |
| Supervised strength training (group 1) | Experimental | Other: Supervised strength training (group 1)In-person, supervised muscle strengthening exercises twice weekly at a specific intensity. |
| Supervised strength training (group 2) | Experimental | Other: Supervised strength training (group 2)In-person, supervised muscle strengthening exercises twice weekly at a specific intensity. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 50 or over
- Has received 2 vaccines for COVID-19
- Has femoral neck, total hip, or lumbar spine BMD T-score of ≤ -1, OR has been or have a FRAX probability of fracture of greater than or equal to 20% for major osteoporotic fracture or 3% or greater for hip fracture.*
- Willing to participate in 2x weekly exercise sessions
- Self-reported as postmenopausal for ≥ 2 years, OR postmenopausal stats confirmed via blood test (female participants only)
Key exclusion criteria (13 listed)
- Is unable to communicate in English
- Has conditions affecting bone health
- Takes or has taken medications affecting bone in the last 12 months or longer (as determined by the research team)
- Has had a clinical or symptomatic spine fracture in the last 12 months, or a lower/upper limb fracture in the last 6 months
- Has had a joint replacement in the last 6 months
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 |
|---|---|---|
| Supervised strength training (group 1)Participants in this arm will complete twice weekly resistance training. They will focus on form initially, and then be progressed to 3 sets of 10-12 repetitions at an intensity of ~70% of estimated 1 repetition maximum. | Other | Supervised strength training (group 1) |
| Supervised strength training (group 2)Participants in this arm will complete twice weekly resistance training. They will focus on form initially, and then be progressed to 3 sets of ~4-6 repetitions at an intensity of 85% of estimated one repetition maximum, with a warm-up set of 8 repetitions at their estimated 70% estimated one repetition maximum to attempt to match the volume performed in the other resistance training group. | Other | Supervised strength training (group 2) |
| Home exerciseParticipants in this arm will complete twice-weekly upper and lower body exercises at home, focused on posture and balance. Participants will meet 1:1 with an exercise physiologist who will select and prescribe exercises. Participants will also be invited to attend twice monthly virtual exercise and education sessions. | Other | Home exercise |
Primary outcome
Lumbar Spine bone mineral density (BMD)
Time frame: Baseline and 12 months
Lumbar spine (L1-L4) bone mineral density measured via dual-energy X-ray Absorptiometry (DXA) scan.
30 secondary outcomes
Fractures
Time frame: Over 12 months
Rate of falls per person per year
Time frame: Over 12 months
Number of people who experience one or more falls
Time frame: Over 12 months
Bone-free lean mass
Time frame: Baseline and 12 months
Appendicular lean mass
Time frame: Baseline and 12 months
Height
Time frame: Baseline and 12 months
Occiput-to-wall distance
Time frame: Baseline and 12 months
Knee extension peak torque
Time frame: Baseline, 6 months, and 12 months
30 Second Chair Stand Test.
Time frame: Baseline, 6 months, and 12 months
Four Square Step Test
Time frame: Baseline, 6 months, and 12 months
Grip Strength
Time frame: Baseline, 6 months, and 12 months
10 Metre Walk Test.
Time frame: Baseline, 6 months, and 12 months
6 Minute Walk Test.
Time frame: Baseline, 6 months, and 12 months
Osteoporosis-specific quality of life (QUALEFFO-41)
Time frame: Baseline, 6 months, and 12 months
Quality of life (EQ5D5L)
Time frame: Baseline, 6 months, and 12 months
Serious adverse events
Time frame: Over 12 months
Non-serious adverse events
Time frame: Over 12 months
Glucose concentration
Time frame: Baseline and 6 months
Insulin concentration
Time frame: Baseline and 6 months
Pro/anti-inflammatory markers
Time frame: Baseline and 6 months
Oxidative stress markers/antioxidant status (including oxygen radical absorbance capacity (ORAC) assay, protein carbonyls, glutathione peroxidase activity, thioredoxin, malondialdehyde)
Time frame: Baseline and 6 months
peptides synthesized and released by myocytes in muscle tissue
Time frame: Baseline and 6 months
Total Hip BMD
Time frame: Baseline and 12 months
Femoral Neck BMD
Time frame: Baseline and 12 months
Trabecular Bone Score
Time frame: Baseline and 12 months
Hip Geometry
Time frame: Baseline and 12 months
Health Service Use
Time frame: Baseline, 6 months, and 12 months
Ratio of costs to QALY
Time frame: Baseline, 6 months, and 12 months
Willingness to pay
Time frame: Baseline, 6 months, and 12 months
Body weight
Time frame: Baseline, 6 months and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Background: PubMed 11069188Cauley JA, Thompson DE, Ensrud KC, Scott JC, Black D. Risk of mortality following clinical fractures. Osteoporos Int. 2000;11(7):556-61. doi: 10.1007/s001980070075.
- Background: PubMed 11176842Lindsay R, Silverman SL, Cooper C, Hanley DA, Barton I, Broy SB, Licata A, Benhamou L, Geusens P, Flowers K, Stracke H, Seeman E. Risk of new vertebral fracture in the year following a fracture. JAMA. 2001 Jan 17;285(3):320-3. doi: 10.1001/jama.285.3.320.
- Background: PubMed 19654194Ioannidis G, Papaioannou A, Hopman WM, Akhtar-Danesh N, Anastassiades T, Pickard L, Kennedy CC, Prior JC, Olszynski WP, Davison KS, Goltzman D, Thabane L, Gafni A, Papadimitropoulos EA, Brown JP, Josse RG, Hanley DA, Adachi JD. Relation between fractures and mortality: results from the Canadian Multicentre Osteoporosis Study. CMAJ. 2009 Sep 1;181(5):265-71. doi: 10.1503/cmaj.081720. Epub 2009 Aug 4.
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- 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.
Lora Giangregorio, PhD principal investigator
University of Waterloo
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised strength training (group 1), Supervised strength training (group 2) and Home exercise in people with Osteoporosis and Osteopenia, run by University of Waterloo at 3 sites in Canada.
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 6 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: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Lumbar Spine bone mineral density (BMD) (time frame: Baseline and 12 months). 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 NCT05541432, which also lists 14 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 23 Jul 2026.