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Parathyroid Hormone for the Treatment of Humerus Fractures
Plain-language guide to NCT01687374: phase 4 randomized trial of Parathyroid Hormone (PTH 1-84), 72 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01687374
- Phase
- phase 4
- Status
- status unknown
- Start
- 2012-03
- Completion (planned or actual)
- 2012-12
- Participants
- 72 (estimated)
- Design
- randomized, quadruple-blind, treatment
- Conditions studied
- Shoulder Fractures
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Parathyroid Hormone (PTH 1-84).
The investigators will assess healing of the humerus with Constant score.
It had two arms (groups): Placebo (placebo comparator) and Parathyroid hormone (experimental).
The registry classes the interventions as drug.
Who Took Part
72 planned participants were the target.
It was open to people of any sex aged from 65 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Proximal humeral fracture eligible for conservative treatment. Able to understand the protocol. Signs an informed consent.
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: liver disease; kidney disease; severe osteoporosis.
How the Study Was Run
The set-up was randomized, parallel-group and quadruple-blind.
The participants were allocated by chance, so the Parathyroid Hormone (PTH 1-84) group and the comparison group should start out alike.
The Parathyroid Hormone (PTH 1-84) group and the comparison group ran side by side rather than switching.
Neither the participants nor the staff measuring them knew who was on Parathyroid Hormone (PTH 1-84), so expectations could not easily colour the readings.
Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.
It started in 2012-03 with completion listed for 2012-12.
It ran at 1 site in Denmark.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Changes in constant score (time frame: 5, 8, 11, 23, and 104 weeks).
It also tracked 4 secondary outcomes, for example Changes in Oxford Shoulder Score, Changes in bone formation evaluated by X-ray, Changes in biochemical bone markers and Changes in regulatory T lymphocytes.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Parathyroid Hormone (PTH 1-84) in 72 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Parathyroid Hormone (PTH 1-84) compound page, all human trials.
Our Notes on the Compound
Parathyroid Hormone (PTH 1-84): The 84-amino-acid hormone that raises blood calcium; full-length PTH (Natpara) has been used in hypoparathyroidism. Teriparatide is its 1-34 fragment.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.