Bone Health in Postmenopausal Women: The Effect of Exercise With or Without Medication for Osteoporosis (BEAT-OP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoporosis in Post-menopausal Women
• Intervention / Treatment: Behavioral: EXERCISE TRAINING; Drug: Antiresorptive medication (routine clinical care)

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.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nora Alohaly, PhD; Phone Number: +441509226207; Email: n.alohaly@lboro.ac.uk

Study Locations

• United Kingdom
  • Leicestershire
    • Loughborough, Leicestershire, United Kingdom, LE11 3TU
      • Loughborough University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

  1. Strength, powerlifting or high load resistance exercise.
  2. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Without any medication affecting bone; 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.	Behavioral: EXERCISE TRAINING; 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.
Experimental: With osteoporosis medication (antiresorptive ); 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.	Behavioral: EXERCISE TRAINING; 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.; Drug: Antiresorptive medication (routine clinical care); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Femoral neck bone mineral content BMC	(g) measured by DXA	Baseline, 6 months and 12 months
Femoral neck bone mineral density BMD	(g/cm^2) measured by DXA	Baseline, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total hip bone mineral content BMC	(g) measured by DXA	Baseline, 6 months and 12 months
Total hip bone mineral density BMD	(g/cm^2) measured by DXA	Baseline, 6 months and 12 months
Lumbar spine bone mineral content BMC	(g) measured by DXA	Baseline, 6 months and 12 months
Lumbar spine bone mineral density BMD	(g/cm^2) measured by DXA	Baseline, 6 months and 12 months
Prevalent vertebral fracture	assessed using DXA vertebral morphology	Baseline, 6 months and 12 months
Whole body composition	weight in Kg	Baseline, 6 months and 12 months
Whole body composition	Hight in cm	Baseline, 6 months and 12 months
Total fat mass	will be measured using whole body DXA, reported in Kg	Baseline, 6 months and 12 months
Lean mass	will be measured using whole body DXA, reported in Kg	Baseline, 6 months and 12 months
Tibia distal (4%) Total volumetric bone density vBMD	(mg/cm^3) measured by pQCT	Baseline, 6 months and 12 months
Tibia distal (4%) trabecular density vBMD	(mg/cm^3) measured by pQCT	Baseline, 6 months and 12 months
Tibia distal (4%)Total bone area	(mm) measured by pQCT	Baseline, 6 months and 12 months
Tibia shaft (66%) cortical content per 1 mm	(mg/mm) measured by pQCT	Baseline, 6 months and 12 months
Tibia shaft (66%) cortical thickness	(mm) measured by pQCT	Baseline, 6 months and 12 months
Tibia shaft (66%) cortical vBMD	(mg/cm^3) measured by pQCT	Baseline, 6 months and 12 months
Femoral neck integral BMC	g measured by QCT	Baseline and 12 months
Femoral neck cortical BMC	g measured by QCT	Baseline and 12 months
Femoral neck trabecular BMC	g measured by QCT	Baseline and 12 months
Proximal femur cortical thickness	mm measured by QCT	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	Baseline, 6 months and 12 months
Hop performance (ground reaction force).	measured by force plate reported in Newtons (N)	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.	Baseline and 12 months
Daily calcium intake	(mg) Calcium Questionnaire	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.	Baseline, 6 months and 12 months
Trochanter BMD	g/cm^2 by DXA	Baseline, 6month and 12month
Trochanter BMC	g by DXA	Baseline, 6month and 12month
Tibia shaft (66%) cortical area	(mm^2) measured by pQCT	Baseline, 6 months and 12 months
Tibia shaft (66%) Periosteal circumference	(mm) measured by pQCT	Baseline, 6 months and 12 months
Tibia shaft (66%) Endosteal circumference	(mm) measured by pQCT	Baseline, 6 months and 12 months
Tibia shaft (66%) Axial area moment of inertia	(mm^4) measured by pQCT	Baseline, 6 months and 12 months
Tibia shaft (66%) Moment of resistance	(mm^3) measured by pQCT	Baseline, 6 months and 12 months
Tibia shaft (66%) Total bone area	(mm^2) measured by pQCT	Baseline, 6 months and 12 months
Tibia shaft (66%) Strength Strain Index	(mm^3) measured by pQCT	Baseline, 6 months and 12 months
Trochanter integral BMC	g measured by QCT	Baseline and 12 months
Trochanter cortical BMC	g measured by QCT	Baseline and 12 months
Trochanter trabecular BMC	g measured by QCT	Baseline and 12 months
Intertrochanter integral BMC	g measured by QCT	Baseline and 12 months
Intertrochanter cortical BMC	g measured by QCT	Baseline and 12 months
Intertrochanter trabecular BMC	g measured by QCT	Baseline and 12 months
Mid-femoral neck geometry	Buckling ratio measured by QCT	Baseline and 12 months
Mid-femoral neck geometry	Cross-sectional moment of inertia minimum (cm^4) measured by QCT	Baseline and 12 months
Mid-femoral neck geometry	Cross-sectional moment of inertia maximum (cm^4) measured by QCT	Baseline and 12 months
Mid-femoral neck geometry	Cross-sectional moment of area (cm^2) measured by QCT	Baseline and 12 months

Collaborators and Investigators

• Sponsor: Loughborough University
• Collaborators: University of Sheffield; University of Cambridge
• Investigators: Principal Investigator: Katherine Brooke-Wavell, Professor, Loughborough University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: December 4, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Biomarkers; Bone mineral density; Fracture risk; Bone strength; Bone structure; Bone geometry
• Additional Relevant MeSH Terms: Behavior; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise
• Other Study ID Numbers: 354429

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No