Parathyroid Hormone for the Treatment of Humerus Fractures

Phase IV Study of the Effect of Parathyroid Hormone on Fractures of the Humerus

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01687374

Enrollment

Registered

2012-09-18

Start date

2012-03-31

Completion date

2013-12-31

Last updated

2012-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Fractures

Keywords

proximal humeral fracture

Brief summary

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.

Interventions

DRUGPlacebo

Saline injection daily for 8 weeks.

DRUG1-84 parathyroid hormone

100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Changes in constant score	5, 8, 11, 23, and 104 weeks.	Constant score summarizes the function of the arm using a questionnaire (activities of daily living - ADL) and functional testing of the arm.

Secondary

Measure	Time frame	Description
Changes in Oxford Shoulder Score	5, 8, 11, 23, and 104 weeks.	Oxford shoulder score is a questionnaire that assesses the function of the arm through the evaluation of the participant.
Changes in bone formation evaluated by X-ray.	5, 8, 11, 23, and 104 weeks.	—
Changes in biochemical bone markers	0, 5, 25 weeks	sodium, potassium, creatinine, liver enzymes, vitamin D, parathyroid hormone, alkaline phosphatase, hemoglobin, magnesium, calcium, zinc.
Changes in regulatory T lymphocytes	0, 8, 24 weeks	Regulatory CD3+CD4+CD25+Foxp3+ T lymphocytes.

Countries

Denmark

Contacts

Primary ContactLars Hyldstrup, MDSc

hyld@dadlnet.dk

Backup ContactUlrich C Bang, M.D.

ulrichbangbang@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026