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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age55-75
SponsorLoughborough University

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Without any medication affecting boneExperimental treatment 1 intervention
Group B: With osteoporosis medication (antiresorptive )Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Femoral neck bone mineral content BMC

(g) measured by DXA

Time frame
Baseline, 6 months and 12 months
2

Femoral neck bone mineral density BMD

(g/cm\^2) measured by DXA

Time frame
Baseline, 6 months and 12 months

Secondary outcomes

1

Total hip bone mineral content BMC

(g) measured by DXA

Time frame
Baseline, 6 months and 12 months
2

Total hip bone mineral density BMD

(g/cm\^2) measured by DXA

Time frame
Baseline, 6 months and 12 months
3

Lumbar spine bone mineral content BMC

(g) measured by DXA

Time frame
Baseline, 6 months and 12 months
4

Lumbar spine bone mineral density BMD

(g/cm\^2) measured by DXA

Time frame
Baseline, 6 months and 12 months

Other outcomes

Sponsors and contacts

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Loughborough University

Lead sponsor

University of Sheffield

Collaborator

University of Cambridge

Collaborator

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