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NCT Number: NCT07267325

Bone Health in Postmenopausal Women: The Effect of Exercise With or Without Medication for Osteoporosis

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.

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Key information

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Loughborough University

Loughborough, Leicestershire, LE11 3TU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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.

Exclusion criteria

  • 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)

Treatment and study plan

Exercise Training

Behavioral

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.

Primary outcomes

  1. Femoral neck bone mineral content BMC

    Time frame: Baseline, 6 months and 12 months

    (g) measured by DXA

  2. Femoral neck bone mineral density BMD

    Time frame: Baseline, 6 months and 12 months

    (g/cm^2) measured by DXA

Secondary outcomes

  1. Total hip bone mineral content BMC

    Time frame: Baseline, 6 months and 12 months

    (g) measured by DXA

  2. Total hip bone mineral density BMD

    Time frame: Baseline, 6 months and 12 months

    (g/cm^2) measured by DXA

  3. Lumbar spine bone mineral content BMC

    Time frame: Baseline, 6 months and 12 months

    (g) measured by DXA

  4. Lumbar spine bone mineral density BMD

    Time frame: Baseline, 6 months and 12 months

    (g/cm^2) measured by DXA

  5. Prevalent vertebral fracture

    Time frame: Baseline, 6 months and 12 months

    assessed using DXA vertebral morphology

  6. Whole body composition

    Time frame: Baseline, 6 months and 12 months

    weight in Kg

  7. Whole body composition

    Time frame: Baseline, 6 months and 12 months

    Hight in cm

  8. Total fat mass

    Time frame: Baseline, 6 months and 12 months

    will be measured using whole body DXA, reported in Kg

  9. Lean mass

    Time frame: Baseline, 6 months and 12 months

    will be measured using whole body DXA, reported in Kg

  10. Tibia distal (4%) Total volumetric bone density vBMD

    Time frame: Baseline, 6 months and 12 months

    (mg/cm^3) measured by pQCT

  11. Tibia distal (4%) trabecular density vBMD

    Time frame: Baseline, 6 months and 12 months

    (mg/cm^3) measured by pQCT

  12. Tibia distal (4%)Total bone area

    Time frame: Baseline, 6 months and 12 months

    (mm) measured by pQCT

  13. Tibia shaft (66%) cortical content per 1 mm

    Time frame: Baseline, 6 months and 12 months

    (mg/mm) measured by pQCT

  14. Tibia shaft (66%) cortical thickness

    Time frame: Baseline, 6 months and 12 months

    (mm) measured by pQCT

  15. Tibia shaft (66%) cortical vBMD

    Time frame: Baseline, 6 months and 12 months

    (mg/cm^3) measured by pQCT

  16. Femoral neck integral BMC

    Time frame: Baseline and 12 months

    g measured by QCT

  17. Femoral neck cortical BMC

    Time frame: Baseline and 12 months

    g measured by QCT

  18. Femoral neck trabecular BMC

    Time frame: Baseline and 12 months

    g measured by QCT

  19. Proximal femur cortical thickness

    Time frame: Baseline and 12 months

    mm measured by QCT

  20. Plasma bone turnover biomarkers (resorption marker)

    Time frame: Baseline, 6 months and 12 months

    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

  21. Hop performance (ground reaction force).

    Time frame: Baseline, 6 months and 12 months

    measured by force plate reported in Newtons (N)

  22. Total Bone-specific Physical Activity Questionnaire (BPAQ) score

    Time frame: Baseline and 12 months

    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.

  23. Daily calcium intake

    Time frame: Baseline, 6 months and 12 months

    (mg) Calcium Questionnaire

  24. Fall and balance confidence

    Time frame: Baseline, 6 months and 12 months

    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.

  25. Trochanter BMD

    Time frame: Baseline, 6month and 12month

    g/cm^2 by DXA

  26. Trochanter BMC

    Time frame: Baseline, 6month and 12month

    g by DXA

  27. Tibia shaft (66%) cortical area

    Time frame: Baseline, 6 months and 12 months

    (mm^2) measured by pQCT

  28. Tibia shaft (66%) Periosteal circumference

    Time frame: Baseline, 6 months and 12 months

    (mm) measured by pQCT

  29. Tibia shaft (66%) Endosteal circumference

    Time frame: Baseline, 6 months and 12 months

    (mm) measured by pQCT

  30. Tibia shaft (66%) Axial area moment of inertia

    Time frame: Baseline, 6 months and 12 months

    (mm^4) measured by pQCT

  31. Tibia shaft (66%) Moment of resistance

    Time frame: Baseline, 6 months and 12 months

    (mm^3) measured by pQCT

  32. Tibia shaft (66%) Total bone area

    Time frame: Baseline, 6 months and 12 months

    (mm^2) measured by pQCT

  33. Tibia shaft (66%) Strength Strain Index

    Time frame: Baseline, 6 months and 12 months

    (mm^3) measured by pQCT

  34. Trochanter integral BMC

    Time frame: Baseline and 12 months

    g measured by QCT

  35. Trochanter cortical BMC

    Time frame: Baseline and 12 months

    g measured by QCT

  36. Trochanter trabecular BMC

    Time frame: Baseline and 12 months

    g measured by QCT

  37. Intertrochanter integral BMC

    Time frame: Baseline and 12 months

    g measured by QCT

  38. Intertrochanter cortical BMC

    Time frame: Baseline and 12 months

    g measured by QCT

  39. Intertrochanter trabecular BMC

    Time frame: Baseline and 12 months

    g measured by QCT

  40. Mid-femoral neck geometry

    Time frame: Baseline and 12 months

    Buckling ratio measured by QCT

  41. Mid-femoral neck geometry

    Time frame: Baseline and 12 months

    Cross-sectional moment of inertia minimum (cm^4) measured by QCT

  42. Mid-femoral neck geometry

    Time frame: Baseline and 12 months

    Cross-sectional moment of inertia maximum (cm^4) measured by QCT

  43. Mid-femoral neck geometry

    Time frame: Baseline and 12 months

    Cross-sectional moment of area (cm^2) measured by QCT

Study contacts

Contact information is provided by the study sponsor or research team.

Nora Alohaly, PhD

CONTACT

[email protected]

+441509226207

Sponsors and collaborators

Lead sponsor

Loughborough University

Other

Collaborators

  • University of Cambridge
  • University of Sheffield

Registry information

Official study title

The Effect of Exercise With or Without Antiresorptive Therapy, on Bone Properties in Postmenopausal Women With Low BMD - Randomised Controlled Unilateral Intervention Trial

Acronym: BEAT-OP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 5, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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