Osteoporosis in Post-menopausal WomenBEAT-OPNCT07267325
Bone Health in Postmenopausal Women: The Effect of Exercise With or Without Medication for Osteoporosis
A study testing EXERCISE TRAINING and Antiresorptive medication (routine clinical care) in people with Osteoporosis in Post-menopausal Women, run by Loughborough University at 1 site in United Kingdom.
Trial summary
Osteoporosis is a systemic bone disorder characterised by a reduced bone mass and structural deterioration, increasing the risk of fragility fractures, particularly in women post-menopause. Bone mass and structure can be assessed by scans. Read more about this study
- Who is it for?
- Ages 55 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis in Post-menopausal Women
- What is being tested?
- EXERCISE TRAINING and Antiresorptive medication (routine clinical care)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2026to Sep 2027
- Phase
- Interventional
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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women aged 55-75 years old
- >4y since menopause/hysterectomy/oophorectomy.
- Baseline femoral neck or lumber spine BMD T-score between -1 and -3.
- Able to complete the hopping exercises.
- Have no regular involvement for more than once/week in:
- Strength, powerlifting or high load resistance exercise.
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- High to moderate impact exercise that known to involve ground reaction forces 2 to 4 times greater than body weight (e.g. Jogging).
- Treatment group: taking antiresorptive treatment for osteoporosis continuously for at least 12 months, and who intend to continue this medication for the rest of the study.
- Control group: not taking any medication affecting bone and no intention to commence such medication for the rest of the study.
Who cannot join
- Body mass index (BMI) >35 kg/m2
- Any medical condition, surgery, or injuries that contraindicate exercises including lower limb or back pain, knee or hip osteoarthritis.
- Vertebral fracture or multiple low trauma fractures (recent expert consensus recommends lower impact exercise for these groups)
- Replacement of hip joint(s)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Loughborough University
Loughborough, Leicestershire, LE11 3TU
About this study
Official title: The Effect of Exercise With or Without Antiresorptive Therapy, on Bone Properties in Postmenopausal Women With Low BMD - Randomised Controlled Unilateral Intervention Trial
Osteoporosis is a systemic bone disorder characterised by a reduced bone mass and structural deterioration, increasing the risk of fragility fractures, particularly in women post-menopause. Bone mass and structure can be assessed by scans.
Antiresorptive medications are commonly prescribed to reduce bone resorption, preventing further bone loss and thus reducing the possibility of fracture. Exercise can also benefit bone mass and structure but current evidence do not show whether exercise is more, or less, effective in combination with antiresorptive medication.
This study will compare the effect of a brief, home-based exercise programme on bone mineral and structural properties in women taking/ not taking antiresorptive medication.
Read the detailed description
Exercise can benefit bone density and induce structural changes, leading to a decrease in fracture risk. High-impact exercise is often recommended for promoting bone health as it generates the brief, high strains that stimulate bone adaptation. Brief multidirectional hopping exercises have been demonstrated to be a practical and sustainable intervention with older men, pre- and postmenopausal women. They allow exercise to be conducted on one leg, whilst changes in the other leg can be used as a control to compare what would happen without exercise.
The effects of exercise on bone density and structure may be different in women taking osteoporosis medication, but few studies have examined this group. This study thus aims to evaluate the effects of exercise on bone density and structure according to osteoporosis medication use.
The study will be a 12-month long randomised controlled trial including two groups: with and without antiresorptive osteoporosis medication for at least 12 months. Participants must not plan to change their treatment choices during the 12-month study. All participants will complete a 12-month unilateral hopping exercise intervention.
Screening and baseline measurements will include dual X-ray absorptiometry (DXA) and computed tomography (CT) scans of the hip, blood collection, hop assessment and questionnaires. Eligible participants will then be invited to commence the exercise intervention and randomly allocated an exercise leg, with the contralateral leg being untrained to provide a control leg. Randomisation of exercise and control legs will be performed by selecting an opaque sealed envelopes which contain "R" or "L" letters. It is not possible to blind the participant or researchers supervising the intervention to leg allocation.
An initial familiarisation session will be conducted under supervision. The exercise intervention involves a home-based exercise programme starting at three days per week, with the goal of increasing to seven days per week. It will begin with a warm-up targeting the legs and lower back, followed by a progressive exercise regimen that will gradually increase in technique, intensity, and frequency to ensure safety. It will be personalised according to the participants' physical abilities and responses during or after the exercise. Weekly supervised group sessions will be offered, and used to advise participants on progression of exercise. An exercise logbook will monitor adherence. A questionnaire on any injuries, soreness, or discomfort will be administered monthly online or by phone. Participants will be instructed to reduce intensity and frequency or discontinue exercise if they experience any adverse symptoms or discomfort.
Follow-up measurements will be conducted six and twelve months after the start of the exercise intervention is completed. All measurements , except for the CT scan, will also be repeated after six months with each visit expected to last no more than two hours. whereas at twelve months, all measurements will be repeated. CT scans will take place at Glenfield Hospital, Leicester. All other visits will take place at Loughborough University.
- Conditions
- Osteoporosis in Post-menopausal Women
- Being tested
- EXERCISE TRAINING, Antiresorptive medication (routine clinical care)
- Keywords
- Exercise, Bone mineral density, Bone strength, Bone geometry, Fracture risk, Bone structure, Biomarkers
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAININGBehavioural
The unilateral high-impact (hopping) exercise will be on one randomly allocated exercise leg, with the contralateral leg being untrained to provide a control leg. Each session will begin with a warm-up targeting the legs and lower back. The progressive exercise regimen consists of multidirectional hopping exercises that will gradually increase in technique, intensity, and frequency to ensure safety. It will be personalised according to the participants' physical abilities and responses during or after the exercise.
Antiresorptive medication (routine clinical care)Drug
Participants in this arm are already taking prescribed antiresorptive medication as part of standard clinical care. The study will not provide or modify the medication.
| Study group | Role | What they receive |
|---|---|---|
| Without any medication affecting bone | Experimental | Participants in this arm are postmenopausal women with low bone density who are not taking any bone medication for at least 12 months. They will participate in a 12-month supervised high impact unilateral hopping exercise. Receives: Behavioral: EXERCISE TRAINING |
| With osteoporosis medication (antiresorptive ) | Experimental | Participants in this arm are postmenopausal women with low bone density who are taking antiresorptive medication for at least 12 months. They will participate in a 12-month supervised high impact unilateral hopping exercise. Receives: Behavioral: EXERCISE TRAINING; Drug: Antiresorptive medication (routine clinical care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral neck bone mineral content BMC
(g) measured by DXA
Measured: Baseline, 6 months and 12 months
Femoral neck bone mineral density BMD
(g/cm^2) measured by DXA
Measured: Baseline, 6 months and 12 months
Secondary outcomes (43)
Total hip bone mineral content BMC
(g) measured by DXA
Measured: Baseline, 6 months and 12 months
Total hip bone mineral density BMD
(g/cm^2) measured by DXA
Measured: Baseline, 6 months and 12 months
Lumbar spine bone mineral content BMC
(g) measured by DXA
Measured: Baseline, 6 months and 12 months
Lumbar spine bone mineral density BMD
(g/cm^2) measured by DXA
Measured: Baseline, 6 months and 12 months
Prevalent vertebral fracture
assessed using DXA vertebral morphology
Measured: Baseline, 6 months and 12 months
Whole body composition
weight in Kg
Measured: Baseline, 6 months and 12 months
Whole body composition
Hight in cm
Measured: Baseline, 6 months and 12 months
Total fat mass
will be measured using whole body DXA, reported in Kg
Measured: Baseline, 6 months and 12 months
Lean mass
will be measured using whole body DXA, reported in Kg
Measured: Baseline, 6 months and 12 months
Tibia distal (4%) Total volumetric bone density vBMD
(mg/cm^3) measured by pQCT
Measured: Baseline, 6 months and 12 months
Tibia distal (4%) trabecular density vBMD
(mg/cm^3) measured by pQCT
Measured: Baseline, 6 months and 12 months
Tibia distal (4%)Total bone area
(mm) measured by pQCT
Measured: Baseline, 6 months and 12 months
Tibia shaft (66%) cortical content per 1 mm
(mg/mm) measured by pQCT
Measured: Baseline, 6 months and 12 months
Tibia shaft (66%) cortical thickness
(mm) measured by pQCT
Measured: Baseline, 6 months and 12 months
Tibia shaft (66%) cortical vBMD
(mg/cm^3) measured by pQCT
Measured: Baseline, 6 months and 12 months
Femoral neck integral BMC
g measured by QCT
Measured: Baseline and 12 months
Femoral neck cortical BMC
g measured by QCT
Measured: Baseline and 12 months
Femoral neck trabecular BMC
g measured by QCT
Measured: Baseline and 12 months
Proximal femur cortical thickness
mm measured by QCT
Measured: Baseline and 12 months
Plasma bone turnover biomarkers (resorption marker)
Bone turnover will be assessed using blood samples to measure C-terminal telopeptide of type I collagen (CTX) which will be reported in µg/L where higher values reflect higher bone turnover, which is associated with increased bone loss
Measured: Baseline, 6 months and 12 months
Hop performance (ground reaction force).
measured by force plate reported in Newtons (N)
Measured: Baseline, 6 months and 12 months
Total Bone-specific Physical Activity Questionnaire (BPAQ) score
Total score from the Bone specific Physical Activity Questionnaire will be calculated based on physical activity, intensity and frequency The questionnaire does not have a fixed minimum or maximum score, and values depend on each participant's activity history.
Higher scores indicate higher levels of bone loading physical activity. The contribution of this activity to skeletal adaptation.
Measured: Baseline and 12 months
Daily calcium intake
(mg) Calcium Questionnaire
Measured: Baseline, 6 months and 12 months
Fall and balance confidence
will be assessed using Short Falls Efficacy Scale International (short- FES-I). The scale includes 7 items, each scored from 1 (Not at all concerned) to 4 (Very concerned).
Total scores range from 7 to 28, where higher scores indicate lower confidence and greater fear of falling.
Measured: Baseline, 6 months and 12 months
Trochanter BMD
g/cm^2 by DXA
Measured: Baseline, 6month and 12month
Trochanter BMC
g by DXA
Measured: Baseline, 6month and 12month
Tibia shaft (66%) cortical area
(mm^2) measured by pQCT
Measured: Baseline, 6 months and 12 months
Tibia shaft (66%) Periosteal circumference
(mm) measured by pQCT
Measured: Baseline, 6 months and 12 months
Tibia shaft (66%) Endosteal circumference
(mm) measured by pQCT
Measured: Baseline, 6 months and 12 months
Tibia shaft (66%) Axial area moment of inertia
(mm^4) measured by pQCT
Measured: Baseline, 6 months and 12 months
Tibia shaft (66%) Moment of resistance
(mm^3) measured by pQCT
Measured: Baseline, 6 months and 12 months
Tibia shaft (66%) Total bone area
(mm^2) measured by pQCT
Measured: Baseline, 6 months and 12 months
Tibia shaft (66%) Strength Strain Index
(mm^3) measured by pQCT
Measured: Baseline, 6 months and 12 months
Trochanter integral BMC
g measured by QCT
Measured: Baseline and 12 months
Trochanter cortical BMC
g measured by QCT
Measured: Baseline and 12 months
Trochanter trabecular BMC
g measured by QCT
Measured: Baseline and 12 months
Intertrochanter integral BMC
g measured by QCT
Measured: Baseline and 12 months
Intertrochanter cortical BMC
g measured by QCT
Measured: Baseline and 12 months
Intertrochanter trabecular BMC
g measured by QCT
Measured: Baseline and 12 months
Mid-femoral neck geometry
Buckling ratio measured by QCT
Measured: Baseline and 12 months
Mid-femoral neck geometry
Cross-sectional moment of inertia minimum (cm^4) measured by QCT
Measured: Baseline and 12 months
Mid-femoral neck geometry
Cross-sectional moment of inertia maximum (cm^4) measured by QCT
Measured: Baseline and 12 months
Mid-femoral neck geometry
Cross-sectional moment of area (cm^2) measured by QCT
Measured: Baseline 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 posted5 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis in Post-menopausal WomenStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loughborough University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield, University of Cambridge
- Responsible party
- Principal investigator, Katherine Brooke-Wavell, Loughborough University
- Investigators
- Katherine Brooke-Wavell, Professor, Principal investigator, Loughborough University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267325
- Sponsor's protocol ID
- 354429
- Acronym
- BEAT-OP
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No