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

What Was Tested

This clinical study looks at Parathyroid Hormone (PTH 1-84).

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.

Why It Was Studied

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.

WBV has been found to stimulate muscle and bone growth.

Who Took Part

By PubMed's age tags, the people studied were middle-aged adults, older adults and people over 80, women only.

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).

How the Study Was Run

The design is described as randomized and multicenter.

The participants were allocated by chance, so the Parathyroid Hormone (PTH 1-84) group and the comparison group should start out alike.

Running at several centres spread the Parathyroid Hormone (PTH 1-84) study over different clinics and patient groups.

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.

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.

What Was Measured

PubMed files the paper under topics including Bone Density, Bone Remodeling, Combined Modality Therapy, Data Interpretation, Statistical, Exercise Therapy, Osteoporosis and Parathyroid Hormone.

The authors tagged it with the keywords Bone mineral density, Bone quality, RCT, Teriparatide and Whole-body vibration.

What This Means in Plain Language

The paper is a randomized and multicenter study of Parathyroid Hormone (PTH 1-84).

Its findings take up roughly 1 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2018 (Trials), a journal based in England.

More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.