PTH and Vibration in OSteoporosis Study

NCT02563353 | Completed DMC

• 1 other identifier: S-20150121
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoporosis

Keywords

whole body vibration; PTH

Outcome Measures

Primary Outcomes (1)

• Changes in the BMD, Bone Mineral Density of hip and spine region (Hologic DXA machine)

  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 Outcomes (13)

• Changes in the 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

  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

  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

  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

  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

Study Arms (3)

controlgroup

ACTIVE COMPARATOR

Teriparatide, 20 microgram/day. 24 months of treatment

Drug: teriparatide

studygroup 1

EXPERIMENTAL

Teriparatide, 20 microgram/day. 24 months of treatment. 12 months of Whole-body vibration on vibration platforms.

Other: whole-body vibration; Drug: teriparatide

studygroup 2

EXPERIMENTAL

Teriparatide, 20 microgram/day. 24 months of treatment. 24 months of Whole-body vibration on vibration platforms

Other: whole-body vibration; Drug: teriparatide

Interventions

whole-body vibration OTHER

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.

Also known as: vibration therapy

studygroup 1; studygroup 2

teriparatide DRUG

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

Also known as: PTH

controlgroup; studygroup 1; studygroup 2

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women starting PTH treatment for osteoporosis according to Danish Osteoporosis guidelines

You may not qualify if:

• 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)

Sponsors & Collaborators

• Odense University Hospital: lead
• University of Southern Denmark: collaborator
• Copenhagen University Hospital, Denmark: collaborator
• Esbjerg Hospital - University Hospital of Southern Denmark: collaborator
• Sygehus Lillebaelt: collaborator
• Odense Patient Data Explorative Network: collaborator
• Region of Southern Denmark: collaborator

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (44)

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  PMID: 32944251 DERIVED

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  PMID: 31309239 DERIVED

• Jepsen 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 DERIVED

MeSH Terms

Conditions

Osteoporosis

Interventions

Teriparatide

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Parathyroid Hormone; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Lars Matzen, Clin.Ass.Pro

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Ditte Jepsen, MD, ph.d. student

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Clin. Ass. Professor

Study Record Dates

• First Submitted: September 15, 2015
• First Posted: September 30, 2015
• Study Start: November 1, 2015
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: September 18, 2020

Record last verified: 2020-09

Locations

DK (1)