Abstract
BackgroundPaVOS is a randomized controlled trial (RCT) which aims to address the use of whole-body vibration exercise (WBV) in combination with parathyroid hormone 1-34 fragment teriparatide (PTH 1-34) treatment in patients with osteoporosis. PTH 1-34 is an effective but expensive anabolic treatment for osteoporosis. WBV has been found to stimulate muscle and bone growth. Animal studies have shown a beneficial effect on bone when combining PTH 1-34 with mechanical loading. A combined treatment with PTH 1-34 and WBV may potentially have beneficial effects on bone and muscles, and reduce fracture risk.Methods/designPaVOS is a multicenter, assessor-blinded, superiority, two-armed randomized controlled trial (RCT).Postmenopausal women (n = 40, aged 50 years and older) starting taking PTH 1-34 from outpatient clinics will be randomized and assigned to a PTH 1-34 + WBV-exercise group (intervention group), or a PTH 1-34-alone group (control group).The intervention group will undergo WBV three sessions a week (12 min each, including 1:1 ratio of exercise: rest, 30 Hz, 1 mm amplitude) for a 12-month intervention period. Both the intervention and the control group will receive PTH 1-34 treatment (20 μg s.c. daily) for 24 months. After 12 months the WBV group will be re-randomized to stop or continue WBV for an additional 12 months.The primary endpoint, bone mineral density (BMD), will be measured by dual-energy x-ray absorptiometry of the total hip and the lumbar spine.Secondary endpoints, bone microarchitecture and estimated bone strength, will be assessed using high-resolution peripheral quantitative computed tomography (HR-pQCT) of the radius and tibia. Serum bone turnover markers (carboxy-terminal collagen crosslinks (CTX), amino-terminal propeptide of type-I collagen (P1NP), and sclerostin) and functional biomarkers (Timed Up and Go (TUG), Short Physical Performance Battery (SPPB), grip strength, and leg extension power) will be measured to assess the effect on bone turnover, muscle strength, balance, and functionality. Quality of life (EQ-5D), physical activity (IPAQ) and fear of falling (FES-I) will be assessed by questionnaires. Data on adherence and falls incidence will be collected.DiscussionThe PaVOS study will investigate the effects of WBV in combination with PTH 1-34 on bone parameters in postmenopausal women.Trial registrationClinicalTrials.gov, ID: NCT02563353. Registered on 30 September 2015.
Highlights
PaVOS is a randomized controlled trial (RCT) which aims to address the use of whole-body vibration exercise (WBV) in combination with parathyroid hormone 1-34 fragment teriparatide (PTH 1-34) treatment in patients with osteoporosis
The PaVOS study will investigate the effects of WBV in combination with PTH 1-34 on bone parameters in postmenopausal women
Osteoporosis is defined by the World Health Organization (WHO) as a disease with low bone mass and impaired microarchitecture leading to a high risk of fragility fractures [1]
Summary
This is a RCT in osteoporotic patients randomized to PTH 1-34 treatment alone or to combined PTH 1-34 treatment and WBV. The functional biomarkers on the other hand could be affected by the non-blinded design but the study personnel performing the tests are blinded to the allocation and the baseline data is collected before randomization. To limit the possibility of bias by attention, the participants will receive close to an equal amount of contacts by the investigators because of the “at home training design.”. The adherence to the training protocol is patient reported data and is in risk of reportingbias. A previous study found high correlation with the usage of a training logbook to electronic monitoring in the WBV intervention in older adults (overall intraclass correlation coefficient = 0.96), showing a small risk of bias in the collected data on adherence [45].
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