Shoulder FracturesPhase 2NCT00741182
Effect of PTH(1-34) Treatment on Fracture Healing in Vivo
A Phase 2 study testing rhPTH(1-34) in people with Shoulder Fractures and Trochanteric Fractures, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture healing in postmenopausal women with fractures of the hip or shoulder. Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Shoulder Fractures, Trochanteric Fractures
- What is being tested?
- rhPTH(1-34)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2008to Sep 2010
- Phase
- Phase 2
- 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 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute new osteoporotic trochanteric or collum chirurgicum fracture
- Postmenopause
Who cannot join
- Calcium metabolic disease other than osteoporosis
- Diseases known to affect calcium homeostasis
- Dementia
- Hypersensitivity to drug or other components of medication
- pre-existing hypercalcemia
- Decreased kidney function
Show all 13Show fewer
- Increased alkaline phosphatase
- Prior external radiation therapy or brachytherapy of the skeleton
- Skeletal malignancies or bone metastases
- Alcohol and/or drug abuse
- Systemic treatment with corticosteroids within the last four weeks
- Non-cooperating patients
- Patients who do not speak and understand the danish language
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Center for Ageing and Osteoporosis, Glostrup University Hospital
Copenhagen
About this study
The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture healing in postmenopausal women with fractures of the hip or shoulder.
- Conditions
- Shoulder Fractures, Trochanteric Fractures
- Being tested
- rhPTH(1-34)
- Keywords
- Fracture, Osteoporosis, Forsteo, Teriparatide, Fracture healing
- Medical subject headings
- Shoulder Fractures, Hip Fractures, Fractures, Bone, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhPTH(1-34)Drug
Also called Forsteo, Forteo, Teriparatide
Injection of 20 micrograms per day in eight weeks
| Study group | Role | What they receive |
|---|---|---|
| Femur PTH(1-34) | Experimental | 24 participants with trochanteric fractures will be assigned to Forsteo (PTH(1-34)) treatment Receives: Drug: rhPTH(1-34) |
| Femur Control | No intervention | 24 participants with trochanteric fractures will be assigned to "no treatment" |
| Humerus PTH(1-34) | Experimental | 24 participants with collum chirurgicum fracture will be assigned to Forsteo (PTH(1-34)) treatment Receives: Drug: rhPTH(1-34) |
| Humerus Control | No intervention | 24 participants with collum chirurgicum fracture will be assigned to "no treatment". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological evaluation of healing
Measured: 0, 4, 8, 12, (16) weeks after fracture
Secondary outcomes (2)
Biochemical bone markers
Measured: 0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture
SF-36 questionnaire
Measured: 0, 4, 8, 12, (16) weeks after fracture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Medical Research Council
- Investigators
- Peter Schwarz, MD, DMSci, Principal investigator, Glostrup University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741182
- Sponsor's protocol ID
- FAO_06_011
- Other IDs
- EudraCT 2008-000094-37
- Status last verified
- Aug 2009
- First submitted
- 25 Aug 2008
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PTH(1-34) Treatment on Fracture Healing in Vivo
- ClinicalTrials.gov ID
- NCT00741182
- Acronym / sponsor ID
- FAO_06_011
- Conditions
- Shoulder Fractures, Trochanteric Fractures
- Keywords
- Fracture, Osteoporosis, Forsteo, Teriparatide, Fracture healing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- The Danish Medical Research Council
- Study start
- Oct 2008
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 26 Aug 2008 (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.
The purpose of the study is to investigate, whether PTH(1-34) is able to promote fracture healing in postmenopausal women with fractures of the hip or shoulder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Femur PTH(1-34) | Experimental | Drug: rhPTH(1-34)24 participants with trochanteric fractures will be assigned to Forsteo (PTH(1-34)) treatment |
| Femur Control | No intervention | –24 participants with trochanteric fractures will be assigned to "no treatment" |
| Humerus PTH(1-34) | Experimental | Drug: rhPTH(1-34)24 participants with collum chirurgicum fracture will be assigned to Forsteo (PTH(1-34)) treatment |
| Humerus Control | No intervention | –24 participants with collum chirurgicum fracture will be assigned to "no treatment". |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute new osteoporotic trochanteric or collum chirurgicum fracture
- Postmenopause
Key exclusion criteria (13 listed)
- Calcium metabolic disease other than osteoporosis
- Diseases known to affect calcium homeostasis
- Dementia
- Hypersensitivity to drug or other components of medication
- pre-existing hypercalcemia
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 |
|---|---|---|
| rhPTH(1-34)Also: Forsteo, Forteo, TeriparatideInjection of 20 micrograms per day in eight weeks | Drug | Femur PTH(1-34), Humerus PTH(1-34) |
Primary outcome
Radiological evaluation of healing
Time frame: 0, 4, 8, 12, (16) weeks after fracture
2 secondary outcomes
Biochemical bone markers
Time frame: 0, 1, 2, 3, 4, 8, 12, (16) weeks after fracture
SF-36 questionnaire
Time frame: 0, 4, 8, 12, (16) weeks after fracture
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2015.
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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.
Peter Schwarz, MD, DMSci principal investigator
Glostrup University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rhPTH(1-34) in people with Shoulder Fractures and Trochanteric Fractures, run by Glostrup University Hospital, Copenhagen 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 2 inclusion and 13 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: withdrawn, as of the sponsor's last update on 18 Mar 2015. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological evaluation of healing (time frame: 0, 4, 8, 12, (16) weeks after fracture). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Mar 2015.