Parathyroid Hormone for the Treatment of Humerus Fractures

Hvidovre University Hospital

Status and phase: Unknown; Phase 4

Conditions: Shoulder Fractures

Treatments: Drug: 1-84 parathyroid hormone; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01687374

HvH-2011-545-1

Details and patient eligibility

About

Hypothesis:

The investigators want to study whether parathyroid hormone improves healing of humerus after a fracture. The investigators will assess healing of the humerus with Constant score.

Enrollment: 72 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• proximal humeral fracture eligible for conservative treatment.
• able to understand the protocol
• signs an informed consent

Exclusion criteria

• liver disease
• kidney disease
• severe osteoporosis
• malignant disease
• bone metabolic disease
• oral treatment with bisphosphonates during the last 3 months.
• treatment with Denosumab during the last 6 months.
• intravenous treatment with bisphosphonates during the last 12 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Parathyroid hormone

Experimental group

Treatment:

Drug: 1-84 parathyroid hormone