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PTH and Vibration in OSteoporosis Study (PaVOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563353
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : September 18, 2020
Sponsor:
Collaborators:
University of Southern Denmark
Copenhagen University Hospital, Denmark
Hospital of South West Denmark
Sygehus Lillebaelt
Odense Patient Data Explorative Network
Region of Southern Denmark
Information provided by (Responsible Party):
Lars Matzen, Odense University Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Osteoporosis Other: whole-body vibration Drug: teriparatide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PTH and Vibration in OSteoporosis (PaVOS) Study
Actual Study Start Date : November 2015
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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 Name: PTH

Experimental: studygroup 1

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

12 months of Whole-body vibration on vibration platforms.

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 Name: vibration therapy

Drug: teriparatide
Teriparatide, 20 microgram/day. 24 months of treatment.
Other Name: PTH

Experimental: studygroup 2

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

24 months of Whole-body vibration on vibration platforms

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 Name: vibration therapy

Drug: teriparatide
Teriparatide, 20 microgram/day. 24 months of treatment.
Other Name: PTH




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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)

  8. 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)

  9. Adherence to WBV [ Time Frame: During 2 years from the start of the treatment ]
    Self Reporting training log

  10. 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

  11. 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.

  12. 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

  13. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563353


Locations
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Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
University of Southern Denmark
Copenhagen University Hospital, Denmark
Hospital of South West Denmark
Sygehus Lillebaelt
Odense Patient Data Explorative Network
Region of Southern Denmark
Investigators
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Principal Investigator: Lars Matzen, Clin.Ass.Pro Odense University Hospital
Principal Investigator: Ditte Jepsen, MD, ph.d. student University of Southern Denmark
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lars Matzen, MD, Clin. Ass. Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02563353    
Other Study ID Numbers: S-20150121
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: September 18, 2020
Last Verified: September 2020
Keywords provided by Lars Matzen, Odense University Hospital:
whole body vibration
PTH
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents