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. 2018 Mar 16;19(1):186.
doi: 10.1186/s13063-018-2551-5.

The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of OSteoporosis (PaVOS)- study protocol for a randomized controlled trial

Ditte Beck Jepsen  1   2 , Jesper Ryg  3   4 , Niklas Rye Jørgensen  5   6 , Stinus Hansen  4   7 , Tahir Masud  3   4   8
Affiliations

The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of OSteoporosis (PaVOS)- study protocol for a randomized controlled trial

Ditte Beck Jepsen et al. Trials. .

Abstract

Background: 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. 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/design: PaVOS 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.

Discussion: The PaVOS study will investigate the effects of WBV in combination with PTH 1-34 on bone parameters in postmenopausal women.

Trial registration: ClinicalTrials.gov, ID: NCT02563353 . Registered on 30 September 2015.

Keywords: Bone mineral density; Bone quality; Osteoporosis; Parathyroid hormone; RCT; Teriparatide; Whole-body vibration.

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Conflict of interest statement

Ethics approval and consent to participate

This study will be conducted according to the standards of International Conference on Harmonization, Research Ethics Committee regulations, any applicable government regulations (e.g., The Danish Data Protection Agency), and local procedures. The protocol is approved by the Regional Scientific Ethical Committee of Southern Denmark (ref. ID S-20150121) and The Danish Data Protection Agency (2008-58-0035, 13/40496). Any amendments will be submitted to the above ethical committee for approval of the study conduct. The participants are covered by the Danish “Complaint and compensation law in health care.” Written informed consent will be obtained from each participant. The trial is audited in an ongoing manner to insure patient safety. All events and adverse events are audited each year. In case of serious adverse events these will be sent for audit within 2 weeks. The events are audited independent from the trial investigators by The Regional Scientific Ethical Committee of Southern Denmark.

Consent for publication

Not applicable

Competing interests

The investigators have no competing interests in the study.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure with the schedule of enrollment, interventions, and assessments. BMD bone mineral density; Bone turnover biomarkers procollagen type-1 amino-terminal propeptide, carboxy-terminal type-1 collagen crosslinks, sclerostin; HR-pQCT high-resolution peripheral quantitative computed tomography; FES-I Falls Efficacy Scale International; Functional biomarkers: Short Physical Performance Battery, Timed Up and Go, grip strength, leg extension power; IPAQ International Physical Activity Questionnaire.
Fig. 2
Fig. 2
Timeline for participants. Figure 2 shows the timeline for the participants in the study. The x-axis is the time during the study in months. The participants will be randomized after baseline data is collected to an intervention group receiving whole-body vibration (WBV) in addition to PTH 1-34 compared to the control group receiving PTH 1-34 alone. After 12 months the intervention group will be re-randomized. BMD bone mineral density; HR-pQCT high-resolution peripheral quantitative computed tomography; Bone biomarkers procollagen type-1 amino-terminal propeptide (P1NP), carboxy-terminal type-1 collagen crosslinks (CTX), and sclerostin; Physical markers: Timed Up and Go (TUG), Short Physical Performance Battery (SPPB), grip strength and leg extensor power; DXA dual-energy x-ray absorptiometry; IPAQ The International Physical Activity Questionnaire; FES-I Falls Efficacy Scale International
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