Short summary

The purpose of this project is to investigate the effects off combining standard parathyroid hormone (PTH) with Whole-body vibration (WBV) in the treatment of osteoporosis.

PTH is an effective but expensive anabolic treatment for osteoporosis and 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.

The study is a RCT combining WBV with PTH vs PTH alone.

Trial Registration: ClinicalTrials.gov Identifier: NCT02563353

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Rationale

Vertebral fractures are associated with osteoporosis and can lead to significant pain, disability, morbidity, reduced quality of life and cost to health and social services. The PTH fragment teriparatide is the most commonly used anabolic (bone building) agent for the treatment of osteoporosis. The high price restricts its use to osteoporotic patients with the highest fracture risk or who have inadequate response to or cannot tolerate more commonly used anti-resorptive agents such as bisphosphonates.

Thus any intervention that can boost the efficacy of teriparatide could make it more cost-effective. Furthermore, as the length of teriparatide treatment is limited (licensed for up to 18-24 months only), maximizing its response by such augmentation would be desirable, not only in terms of reducing fracture risk in individual patients but also by potential cost-saving implications.

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Description of the cohort

Post-menopausal women over the age of 50 years attending the Osteoporosis Clinics at Odense University Hospital (Svendborg and Odense), or the Geriatric Outpatient Clinic at Odense University Hospital or the Medical outpatient clinic at Hospital Lillebaelt and Hospital of Southwest Denmark will be recruited.

Data and biological material

BMD is assessed using Dual Energy X-ray absorptiometry (DXA) of hip and spine regions (Hologic machine) at 0, 6, 12, 18 and 24 months. Full body DXA is performed at 0, 12 and 24 months.

HRpQCT (Xtreme- CT) assesses parameters of bone microarchitecture at the tibia and radius at 0, 6, 12, 18 and 24 months.

PTH treatment on bone.

Measurements of muscle strength (leg extensor power) and the balance is measured by the PPA "leg extensor force", "The 3 meter timed up and go test", "walking speed" and "Bergs Balance scale". These endpoints will indicate if WBV has potential to reduce the risk of falls in osteoporotic patients, which is another important risk of fracture, independent on the effects on bone. These measurements will be done at 0, 3, 6, 12, 18 and 24 months.

Adherence to WBV is studied. Dropout rates and the reasons for this will be noted.

To eliminate confounding on the topics muscle strength and balance, the exercise habits will be examined by means of questionnaires on physical activity.  

The questionnaires IPAQ, EQ5D and FES-I will be examined at baseline and during the study.   

Collaborating researchers and departments

The Department of Geriatrics, Odense University Hospital

Institute of Clinical Research, University of Southern Denmark

• PhD-student Ditte Jepsen, MD
• Visiting Professor Tahir Masud, MD
• Postdoc. Jesper Ryg, MD, PhD
• Acting Senior Hospital Physician and Clinical Associated Professor Lars Matzen

Department of Endocrinology, Odense University Hospital

• Postdoc. Stinus Hansen, MD, phD

The Department of Biochemistry, Glostrup Hospital

• Professor Niklas Rye Jørgensen, MD, DMSc, PhD

Department of Medicin, Hospital of Southwest Jutland, Esbjerg

Department of Medicin, Little Belt Hospital

Department of Medicin, Odense University Hospital, Svendborg

Publications associated with the project