PTH and Vibration in OSteoporosis Study (PaVOS)

September 17, 2020 updated by: Lars Matzen, Odense University Hospital

PTH and Vibration in OSteoporosis (PaVOS) Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Objectives

  1. To determine if WBV in addition to standard PTH treatment has a greater effect on bone mass in osteoporosis patients compared to standard PTH treatment alone.
  2. To determine if WBV in addition to standard PTH treatment has a greater effect on bone microarchitecture in osteoporosis patients compared to standard PTH treatment alone, as assessed by high resolution peripheral quantitative computed tomography (HR-pQCT).
  3. To determine if WBV in addition to standard PTH treatment has a greater effect on markers of bone formation and resorption in osteoporosis patients compared to standard PTH treatment alone.
  4. To study the effects of WBV on muscle function and balance in osteoporosis
  5. To assess the safety and adherence to WBV in osteoporotic patients

Study Design:

General Design This will be a multi-center randomized controlled trial (RCT) in osteoporosis patients being started on standard PTH treatment according to Danish Osteoporosis guidelines. Participants will be randomized to standard PTH treatment alone or to standard PTH treatment and WBV.

Statistical Plan:

Sample Size Determination The inclusion of 32 participants (16 in both groups) would give the study 80% power to detect a clinically significant additional increase of 22% with WBV (assuming a 9% increase of BMD in the PTH alone group and 11% increase in the combined PTH+WBV group, and assuming a SD of the BMD increase of 2%. Allowing for a 20% dropout rate, the plan is to include 40 participants (20 in each group). From previous research on WBV by one of the investigators (TM), statistically significant differences were found in bone formation markers and in muscle strength at 3 months between the WBV and control groups with a sample size of 35. The number of participants in the latter pilot work is reassuringly consistent with the sample size calculations. The number needed to be included is far less (34%) than the actual number of patients treated with PTH in the recruiting departments in a similar time period last year.

Statistical Methods:

STATA/SPSS will be used for data analysis. For the primary endpoint (BMD at 12 months) the mean percentage changes in BMD between the two groups will be compared using Analysis of Variance (ANOVA) provided the distribution is normal. For the other endpoints parametric tests will be used to assess differences in the two groups for normally distributed data and non-parametric tests for data not normally distributed.

The randomization will be done online in the data capture program Red Cap. There will be created a Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, and normal ranges if relevant.

Information:

Participants will be recruited during their attendance at the outpatient clinics. At that time the subjects will be given a full explanation of the study as well as the patient information sheet and invited to participate in the study. At an interval of not less than 24 hours, patients will be invited to consent prior to starting their PTH treatment.

The information will be sufficient for subjects to make an informed decision about their participation in this study. The subject will complete and sign a consent form to indicate they are giving valid consent to participate in the trial.

Withdrawal of Subjects:

Patients who withdraw consent from participation in the trial will be withdrawn from the trial. This will not affect their standard medical management and not cause any adverse effect on the subject.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: controlgroup
Teriparatide, 20 microgram/day. 24 months of treatment
Drug: teriparatide
Teriparatide, 20 microgram/day. 24 months of treatment.
Other Names:
  • PTH
Experimental: studygroup 1

Teriparatide, 20 microgram/day. 24 months of treatment.

12 months of Whole-body vibration on vibration platforms.
Drug: teriparatide
Teriparatide, 20 microgram/day. 24 months of treatment.
Other Names:
  • PTH
Other: whole-body vibration

Whole-body vibration on vibration platforms. 30-40 Hertz, from 2 mm (low) to 4 mm (high) amplitude,

1 minutes x 6 with 1 minute break between. 3 times a week.

Other Names:
  • vibration therapy
Experimental: studygroup 2

Teriparatide, 20 microgram/day. 24 months of treatment.

24 months of Whole-body vibration on vibration platforms
Drug: teriparatide
Teriparatide, 20 microgram/day. 24 months of treatment.
Other Names:
  • PTH
Other: whole-body vibration

Whole-body vibration on vibration platforms. 30-40 Hertz, from 2 mm (low) to 4 mm (high) amplitude,

1 minutes x 6 with 1 minute break between. 3 times a week.

Other Names:
  • vibration therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
DXA scan of hip and spine regions, BMD (g/cm^2)
at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18, 24 months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
HRpQCT assesses parameters of bone microarchitecture at the tibia.
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
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
HRpQCT assesses parameters of bone microarchitecture at the radius.
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
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
Full body DXA
at the time the participants start treatment and in an interval as close as possible to after 12 and 24 months from baseline
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
CTX, sclerostin
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
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
P1NP
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
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
Measurements of muscle strength (leg extensor power)
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
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
Measurements of muscle strength (handgrip strength)
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
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
Short Physical Performance Battery (SPPB)
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
Adherence to WBV
Time Frame: During 2 years from the start of the treatment
Self Reporting training log
During 2 years from the start of the treatment
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
IPAQ short version
at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
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
EQ5D questionaire.
at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
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
Time up and go test
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
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
FES-I
at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Collaborators

University of Southern Denmark
Sygehus Lillebaelt
Region of Southern Denmark
Odense Patient Data Explorative Network
Copenhagen University Hospital, Denmark
Hospital of South West Jutland

Investigators

  • Principal Investigator: Lars Matzen, Clin.Ass.Pro, Odense University Hospital
  • Principal Investigator: Ditte Jepsen, MD, ph.d. student, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2019

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimate)

September 30, 2015

Study Record Updates

Last Update Posted (Actual)

September 18, 2020

Last Update Submitted That Met QC Criteria

September 17, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20150121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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