Trial · Interventional

CompletedNot applicableRegistry data

PTH and Vibration in OSteoporosis Study

Short name PaVOS

NCTNCT02563353Other idS-20150121

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 35 participants (actual)
Sponsor: Odense University Hospital · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Denmark
Start: Nov 2015
Primary completion: Nov 2018
Completion: Nov 2019
First posted: 30 Sept 2015 (estimated)
Last update posted: 18 Sept 2020
Conditions: Osteoporosis

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201520162017201820192020

N/A
PaVOS
NCT02563353
Nov 2015 to Nov 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Objective: This is a randomized controlled trial (RCT) in osteoporosis patients randomized to standard parathyroid hormone (PTH) treatment alone or to standard PTH treatment and Whole-body vibration (WBV). PTH is an effective but expensive anabolic treatment for osteoporosis. WBV stimulates muscles and bones. A combined treatment might have synergistic or additive beneficial effects on bone, reducing fracture risk making treatment more effective and cost-effective. A beneficial effect on muscles and thereby falls risk of WBV may improve fracture risk even further. If the results of this pilot study are promising then a strong case can be made for a large multi-centre RCT using strong endpoints including fractures and falls.

Interventions

whole-body vibrationOther
teriparatideDrug

Arms3

Active comparator
controlgroup
Teriparatide, 20 microgram/day. 24 months of treatment
Experimental
studygroup 1
Teriparatide, 20 microgram/day. 24 months of treatment. 12 months of Whole-body vibration on vibration platforms.
Experimental
studygroup 2
Teriparatide, 20 microgram/day. 24 months of treatment. 24 months of Whole-body vibration on vibration platforms

Primary outcomes1

Outcomes the sponsor listed as primary.

Changes in the BMD, Bone Mineral Density of hip and spine region (Hologic DXA machine)
Time frame · at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18, 24 months from baseline
Registry description
DXA scan of hip and spine regions, BMD (g/cm\^2)

Secondary outcomes(13)

Changes in the Bone microarchitecture at the tibia
Time frame · at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18 and 24 months from baseline
Registry description
HRpQCT assesses parameters of bone microarchitecture at the tibia.
Changes in the Bone microarchitecture at the radius
Time frame · at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18 and 24 months from baseline
Registry description
HRpQCT assesses parameters of bone microarchitecture at the radius.
changes in muscle mass
Time frame · at the time the participants start treatment and in an interval as close as possible to after 12 and 24 months from baseline
Registry description
Full body DXA
Changes from baseline in the markers of bone resorption
Time frame · at the time the participants start treatment and in an interval as close as possible to after 3, 6, 12, 18, 24 months from baseline
Registry description
CTX, sclerostin
Changes from baseline in the markers of bone formation
Time frame · at the time the participants start treatment and in an interval as close as possible to after 3, 6, 12, 18, 24 months from baseline
Registry description
P1NP
Changes in Muscle strength
Time frame · at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline
Registry description
Measurements of muscle strength (leg extensor power)
Changes in handgrip strength
Time frame · at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline
Registry description
Measurements of muscle strength (handgrip strength)
Changes in Balance
Time frame · at the time the participants start treatment and in an interval as close as possible to after 3, 6 ,12, 18 and 24 months from baseline
Registry description
Short Physical Performance Battery (SPPB)
Adherence to WBV
Time frame · During 2 years from the start of the treatment
Registry description
Self Reporting training log
Changes in physical activity
Time frame · at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
Registry description
IPAQ short version
Changes in quality of life
Time frame · at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
Registry description
EQ5D questionaire.
Changes in basic mobility
Time frame · at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline
Registry description
Time up and go test
Changes in The Falls Efficacy Scale International
Time frame · at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
Registry description
FES-I

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2019

4 results

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.

Jepsen et al. 2019Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USAcited by 43

PMID 31309239PMC6717187DOI 10.1007/s00198-019-05029-zPUB-31309239

Free to read · publisher termsCC BY-NC4 results

Read at source See results (4)

Indexing hint: Randomized controlled trial · 2001

12 results

Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis.

Neer et al. 2001The New England journal of medicinecited by 3,051

PMID 11346808DOI 10.1056/nejm200105103441904PUB-11346808

Rights unknown12 results

Source link See results (12)

More studies

1 study on this page

PubMed tag: none · 2020

The combined effect of parathyroid hormone (1-34) and whole-body vibration exercise on physical performance in OSteoporotic women (PaVOS study): a secondary analysis from a randomised controlled trial.

Jepsen et al. 2020BMC sports science, medicine & rehabilitationcited by 3

PMID 32944251PMC7487945DOI 10.1186/s13102-020-00204-wPUB-32944251

CC BY

Download PDF

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedJepsen DB, Ryg J, Jorgensen NR, Hansen S, Masud T. 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. doi: 10.1186/s13063-018-2551-5. PMID 29548300

Eligibility

Who could join, as posted.

Sex: Female
Age: from 50 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Women starting PTH treatment for osteoporosis according to Danish Osteoporosis guidelines Exclusion Criteria: * Women currently taking oral glucocorticoids * Women unable to give informed consent * Women unable to stand for 2 minutes at a time on the vibration platform * Women who have contraindications to WBV (e.g. joint prosthesis, pacemakers)

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