Evidence map›Paper›PMID 29548300›Full record

ArticleTrials2018

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, Jesper Ryg, Niklas Rye Jørgensen, Stinus Hansen, Tahir Masud

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02563353 (PTH and Vibration in OSteoporosis), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02563353 nacompletednot on this map

PTH and Vibration in OSteoporosis (PaVOS) Study

TypeinterventionalSponsorOdense University HospitalRan2015 to 2019Enrolled35ConditionsOsteoporosisArmswhole-body vibration, teriparatide
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. The impact of Tai Chi on osteoporosis and osteopenia in middle-aged and elderly adults: a systematic review and meta-analysis of randomized controlled trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2026
    Pooled it
  2. The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of postmenopausal OSteoporosis (PaVOS study): a randomized controlled trial.Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA · 2019
    Trial
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 2 countries.

Ditte Beck JepsenDepartment of Geriatric Medicine, Odense University Hospital, Odense, Denmark. Ditte.Beck.Jepsen2@rsyd.dk.
Jesper RygDepartment of Geriatric Medicine, Odense University Hospital, Odense, Denmark.
Niklas Rye JørgensenDepartment of Clinical Biochemistry, Rigshospitalet, Copenhagen, Denmark.
Stinus HansenInstitute of Clinical Research, Faculty of Health Science, University of Southern Denmark, Odense, Denmark.
Tahir MasudDepartment of Geriatric Medicine, Odense University Hospital, Odense, Denmark.
Odense University Hospital · DKRigshospitalet · DKUniversity of Southern Denmark · DK

Funding

OPEN- Odense Patient data Explorative Network (15/36429)The A.P. Møller Foundation for the Advancement of Medical Science (15-177)The Odense University Hospital Research Foundation (1.31.72 Sagsnr.: 12/26914])The Region of Southern Denmark Ph.D. Foundation (J.nr. 13/26005)The Research Foundation between Odense University Hospital and Rigshospitalet (25-A1353)
6 · The paper itself

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. DISCUSSION: The 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.

Indexed as

Randomized Controlled Trials as TopicVibrationAgedAged, 80 and overBone DensityBone RemodelingCombined Modality TherapyData Interpretation, StatisticalEquivalence Trials as TopicExercise TherapyFemaleHumansMiddle AgedMulticenter Studies as TopicOsteoporosisParathyroid HormoneParathyroid HormoneBone mineral densityBone qualityOsteoporosisParathyroid hormoneRCTTeriparatideWhole-body vibration

Identifiers

PMID29548300
PMCPMC5857123
OpenAlexW2792470187

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.