Shoulder FracturesPhase 4NCT01687374
Parathyroid Hormone for the Treatment of Humerus Fractures
A Phase 4 study testing 1-84 parathyroid hormone in people with Shoulder Fractures, run by Hvidovre University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Shoulder Fractures
- What is being tested?
- 1-84 parathyroid hormone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- proximal humeral fracture eligible for conservative treatment.
- able to understand the protocol
- signs an informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Lars Hyldstrup, MDSc contact
Ulrich C Bang, M.D. contact
Denmark1 site, 1 recruiting
- Recruiting
Hvidovre Hospital
Hvidovre, 2650
Lars Hyld, DMSc, hyld@dadlnet.dk
Ulrich C Bang, M.D., ulrichbangbang@gmail.com
About this study
Official title: Phase IV Study of the Effect of Parathyroid Hormone on Fractures of the Humerus
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.
- Conditions
- Shoulder Fractures
- Being tested
- 1-84 parathyroid hormone, Placebo
- Keywords
- proximal humeral fracture
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-84 parathyroid hormoneDrug
100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.
PlaceboDrug
Saline injection daily for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Parathyroid hormone | Experimental | Not described Receives: Drug: 1-84 parathyroid hormone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in constant score
Constant score summarizes the function of the arm using a questionnaire (activities of daily living - ADL) and functional testing of the arm.
Measured: 5, 8, 11, 23, and 104 weeks.
Secondary outcomes (4)
Changes in Oxford Shoulder Score
Oxford shoulder score is a questionnaire that assesses the function of the arm through the evaluation of the participant.
Measured: 5, 8, 11, 23, and 104 weeks.
Changes in bone formation evaluated by X-ray.
Measured: 5, 8, 11, 23, and 104 weeks.
Changes in biochemical bone markers
sodium, potassium, creatinine, liver enzymes, vitamin D, parathyroid hormone, alkaline phosphatase, hemoglobin, magnesium, calcium, zinc.
Measured: 0, 5, 25 weeks
Changes in regulatory T lymphocytes
Regulatory CD3+CD4+CD25+Foxp3+ T lymphocytes.
Measured: 0, 8, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Principal investigator, Ulrich Bang, Hvidovre University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687374
- Sponsor's protocol ID
- HvH-2011-545-1
- Status last verified
- Sep 2012
- First submitted
- 12 Mar 2012
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.
PubMed 19594305Peichl P, Holzer LA, Maier R, Holzer G. Parathyroid hormone 1-84 accelerates fracture-healing in pubic bones of elderly osteoporotic women. J Bone Joint Surg Am. 2011 Sep 7;93(17):1583-7. doi: 10.2106/JBJS.J.01379.
PubMed 21915572
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of the Effect of Parathyroid Hormone on Fractures of the Humerus
- ClinicalTrials.gov ID
- NCT01687374
- Acronym / sponsor ID
- HvH-2011-545-1
- Conditions
- Shoulder Fractures
- Keywords
- proximal humeral fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Mar 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 18 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Parathyroid hormone | Experimental | Drug: 1-84 parathyroid hormone |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- proximal humeral fracture eligible for conservative treatment.
- able to understand the protocol
- signs an informed consent
Key exclusion criteria (8 listed)
- liver disease
- kidney disease
- severe osteoporosis
- malignant disease
- bone metabolic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-84 parathyroid hormone100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection. | Drug | Parathyroid hormone |
| PlaceboSaline injection daily for 8 weeks. | Drug | Placebo |
Primary outcome
Changes in constant score
Time frame: 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.
4 secondary outcomes
Changes in Oxford Shoulder Score
Time frame: 5, 8, 11, 23, and 104 weeks.
Changes in bone formation evaluated by X-ray.
Time frame: 5, 8, 11, 23, and 104 weeks.
Changes in biochemical bone markers
Time frame: 0, 5, 25 weeks
Changes in regulatory T lymphocytes
Time frame: 0, 8, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
- Background: PubMed 19594305Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731.
- Background: PubMed 21915572Peichl P, Holzer LA, Maier R, Holzer G. Parathyroid hormone 1-84 accelerates fracture-healing in pubic bones of elderly osteoporotic women. J Bone Joint Surg Am. 2011 Sep 7;93(17):1583-7. doi: 10.2106/JBJS.J.01379.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Hyldstrup, MDSc contact
Ulrich C Bang, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1-84 parathyroid hormone in people with Shoulder Fractures, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lars Hyldstrup, MDSc (hyld@dadlnet.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in constant score (time frame: 5, 8, 11, 23, and 104 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01687374, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2012.