Health TrialsbyHealthPanel

The Effect of Denosumab on Muscle and Strength and Insulin Sensitivity

ConditionOsteoporosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age40+
SponsorAarhus University Hospital

About this trial

Randomized, placebo controlled prospective trial evaluating the effect of denosumab on insulin sensitivity and muscle strength.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Postmenopausal women (postmenopausal for at least two years)

Age ≥ 40 years

BMD T-score ≥ -2.0 (lumbar spine, total hip or femoral neck)

At least 2 lumbar vertebrae that can be evaluated by dual-energy x-ray absorptiometry (DXA)

Disqualifiers

Treatment for osteoporosis at any time

Other antidiabetic medication than metformin

Low-energy vertebral fractures at any time

Low-energy hip fracture at any time

Trial design

Design model

Parallel

Treatments tested in this trial

  • Denosumab

    Drug

    Denosumab 60 mg

  • Saline (0.9% NaCl)

    Drug

    Placebo

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Study group 1Experimental treatment 1 intervention
Group B: Study group 2Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Insulin sensitivity: HbA1c

Changes in Hb1Ac (mmol/mol) from baseline to month 12

Time frame
12 months
2

Insulin sensitivity: HOMA-IR

Changes in HOMA-IR from baseline to month 12

Time frame
12 months
3

Insulin sensitivity: fasting glucose

Changes in fasting glucose (mmol/l) from baseline to month 12

Time frame
12 months
4

Insulin sensitivity: oral glucose tolerance test

Changes in oral glucose tolerance test (OGTT) (mmol/l) from baseline to month 12

Time frame
12 months

Secondary outcomes

1

DPP-4

Changes in DPP-4 (U/L) from baseline to month 12.

Time frame
12 months
2

GLP-1

Changes in GLP-1 (pmol/L) from baseline to month 12.

Time frame
12 months
3

Bone turnover markers: CTX

Changes in carboxy-terminal collagen crosslinks (CTX) (ug/l) from baseline to month 12.

Time frame
12 months
4

Bone turnover markers: PINP

Changes in procollagen type I N-terminal propeptide (PINP) (ug/L) from baseline to month 12.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aarhus University Hospital

Lead sponsor

Sponsor: MD, Professor, DMSc, PhD Bente Lomholt Langdahl

Collaborator

Source ClinicalTrials.gov
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