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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.
Trials. 2018 Mar 16; 19(1):186.T

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.

Authors+Show Affiliations

Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark. Ditte.Beck.Jepsen2@rsyd.dk. Institute of Clinical Research, Faculty of Health Science, University of Southern Denmark, Odense, Denmark. Ditte.Beck.Jepsen2@rsyd.dk.Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark. Institute of Clinical Research, Faculty of Health Science, University of Southern Denmark, Odense, Denmark.Department of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark. OPEN - Odense Patient data Explorative Network, The University of Southern Denmark, Odense, Denmark.Institute of Clinical Research, Faculty of Health Science, University of Southern Denmark, Odense, Denmark. Department of Endocrinology, Odense University Hospital, Odense, Denmark.Department of Geriatric Medicine, Odense University Hospital, Odense, Denmark. Institute of Clinical Research, Faculty of Health Science, University of Southern Denmark, Odense, Denmark. Department of Geriatric Medicine, Nottingham University Hospitals Trust NHS, Nottingham, UK.

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

29548300

Citation

Jepsen, Ditte Beck, et al. "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." Trials, vol. 19, no. 1, 2018, p. 186.
Jepsen DB, Ryg J, Jørgensen NR, et al. 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. Trials. 2018;19(1):186.
Jepsen, D. B., Ryg, J., Jørgensen, N. R., Hansen, S., & Masud, T. (2018). 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. Trials, 19(1), 186. https://doi.org/10.1186/s13063-018-2551-5
Jepsen DB, et al. 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. Trials. 2018 Mar 16;19(1):186. PubMed PMID: 29548300.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Jepsen,Ditte Beck, AU - Ryg,Jesper, AU - Jørgensen,Niklas Rye, AU - Hansen,Stinus, AU - Masud,Tahir, Y1 - 2018/03/16/ PY - 2017/05/03/received PY - 2018/02/16/accepted PY - 2018/3/18/entrez PY - 2018/3/20/pubmed PY - 2019/3/23/medline KW - Bone mineral density KW - Bone quality KW - Osteoporosis KW - Parathyroid hormone KW - RCT KW - Teriparatide KW - Whole-body vibration SP - 186 EP - 186 JF - Trials JO - Trials VL - 19 IS - 1 N2 - 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. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29548300/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2551-5 DB - PRIME DP - Unbound Medicine ER -