Bone FracturePhase 2NCT00254514
Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures
A Phase 2 study testing somatropin in people with Bone Fracture and Tibia Fractures, run by Novo Nordisk A/S at 40 sites in 9 countries.
Trial summary
This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bone Fracture, Tibia Fractures
- What is being tested?
- somatropin
- How many people
- 407 participants
- Where
- 40 sitesin 9 countries
- Study dates
- Aug 2001to Oct 2003
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary surgical treatment of tibia fracture using intramedullary nailing
- Closed fractures: Tscherne Type C1, C2 and C3
- Open fractures: Gustilo Grade I, II and IIIa
Who cannot join
- Open growth plate on X-rays
- Known chronic endocrine or metabolic disease including diabetes and severe obesity defined as body mass index (BMI)1 > 32.0
- Severe head injury defined as patients who are stuporous or comatose with pupillary enlargement or asymmetry
- Critically ill patients defined as patients in need of mechanical ventilation (except during surgical procedures) or circulatory support (defined as use of inotropic drugs)
Trial locations and contacts
40 sites in 9 countries.
40 sites in 9 countries
Germany11 sites
Novo Nordisk Investigational Site
Augsburg, 86156
Novo Nordisk Investigational Site
Berlin, 13353
Novo Nordisk Investigational Site
Braunschweig, 38118
Novo Nordisk Investigational Site
Hamburg, 20246
Novo Nordisk Investigational Site
Homburg, 66421
Novo Nordisk Investigational Site
Ludwigshafen, 67071
Novo Nordisk Investigational Site
Mainz, 55131
Novo Nordisk Investigational Site
München, 81366
Novo Nordisk Investigational Site
Münster, 48149
Novo Nordisk Investigational Site
Offenbach, 63069
Novo Nordisk Investigational Site
Würzburg, D-97080
Hungary7 sites
Novo Nordisk Investigational Site
Budapest, 1076
Novo Nordisk Investigational Site
Budapest, H-1043
Novo Nordisk Investigational Site
Budapest, H-1081
Novo Nordisk Investigational Site
Budapest, H-1125
Novo Nordisk Investigational Site
Győr, 9024
Novo Nordisk Investigational Site
Miskolc, H-3526
Novo Nordisk Investigational Site
Veszprém, H-8200
Israel5 sites
Novo Nordisk Investigational Site
Beersheba, 84101
Novo Nordisk Investigational Site
Haifa, 31096
Novo Nordisk Investigational Site
Jerusalem, 91120
Novo Nordisk Investigational Site
Kfar Save, 44281
Novo Nordisk Investigational Site
Tel Aviv, 64239
Poland5 sites
Novo Nordisk Investigational Site
Gorzów, 66-400
Novo Nordisk Investigational Site
Krakow, 31-826
Novo Nordisk Investigational Site
Piekary Śląskie, 41-940
Novo Nordisk Investigational Site
Sosnowiec, 41-200
Novo Nordisk Investigational Site
Szczecin-Zdunowo, 70-890
South Africa5 sites
Novo Nordisk Investigational Site
Cape Town, Western Cape, 7505
Novo Nordisk Investigational Site
Cape Town, Western Cape, 7925
Novo Nordisk Investigational Site
Cape Town, Western Cape
Novo Nordisk Investigational Site
Durban, KwaZulu-Natal, 4001
Novo Nordisk Investigational Site
Worcester, 6850
Finland2 sites
Novo Nordisk Investigational Site
Kuopio, 70211
Novo Nordisk Investigational Site
Oulu, 90029
Norway2 sites
Novo Nordisk Investigational Site
Lillestrøm, 2004
Novo Nordisk Investigational Site
Oslo, 0407
Spain2 sites
Novo Nordisk Investigational Site
Madrid, 28041
Novo Nordisk Investigational Site
Valencia, 46026
About this study
Official title: A Multi-centre, Randomised, Double-blind, Placebocontrolled, Parallel-group Trial Investigating the Efficacy and Safety of Norditropin® SimpleXx® in Tibia Fractures
This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. In the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.
- Conditions
- Bone Fracture, Tibia Fractures
- Being tested
- somatropin
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatropinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from surgery until fracture has healed
Measured: During a 12 month period
Secondary outcomes (2)
Investigator's assessment: fracture healed
Number of fractures healed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2005 (estimated)
- Study startAug 2001
- Primary completionOct 2003
- Study completionOct 2003
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 Bone FractureStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 407 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254514
- Sponsor's protocol ID
- NN1606-1365
- Status last verified
- Jan 2017
- First submitted
- 15 Nov 2005
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Raschke M, Rasmussen MH, Govender S, Segal D, Suntum M, Christiansen JS. Effects of growth hormone in patients with tibial fracture: a randomised, double-blind, placebo-controlled clinical trial. Eur J Endocrinol. 2007 Mar;156(3):341-51. doi: 10.1530/EJE-06-0598.
PubMed 17322494Krusenstjerna-Hafstrom T, Rasmussen MH, Raschke M, Govender S, Madsen J, Christiansen JS. Biochemical markers of bone turnover in tibia fracture patients randomly assigned to growth hormone (GH) or placebo injections: Implications for detection of GH abuse. Growth Horm IGF Res. 2011 Dec;21(6):331-5. doi: 10.1016/j.ghir.2011.08.003. Epub 2011 Oct 1.
PubMed 21963127
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Double-blind, Placebocontrolled, Parallel-group Trial Investigating the Efficacy and Safety of Norditropin® SimpleXx® in Tibia Fractures
- ClinicalTrials.gov ID
- NCT00254514
- Acronym / sponsor ID
- NN1606-1365
- Conditions
- Bone Fracture, Tibia Fractures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 407 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003 (actual)
- First posted
- 16 Nov 2005 (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.
This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. In the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary surgical treatment of tibia fracture using intramedullary nailing
- Closed fractures: Tscherne Type C1, C2 and C3
- Open fractures: Gustilo Grade I, II and IIIa
Key exclusion criteria (4 listed)
- Open growth plate on X-rays
- Known chronic endocrine or metabolic disease including diabetes and severe obesity defined as body mass index (BMI)1 > 32.0
- Severe head injury defined as patients who are stuporous or comatose with pupillary enlargement or asymmetry
- Critically ill patients defined as patients in need of mechanical ventilation (except during surgical procedures) or circulatory support (defined as use of inotropic drugs)
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 |
|---|---|---|
| somatropin | Drug | – |
Primary outcome
Time from surgery until fracture has healed
Time frame: During a 12 month period
2 secondary outcomes
Investigator's assessment: fracture healed
Number of fractures healed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
- Results publication: PubMed 17322494Raschke M, Rasmussen MH, Govender S, Segal D, Suntum M, Christiansen JS. Effects of growth hormone in patients with tibial fracture: a randomised, double-blind, placebo-controlled clinical trial. Eur J Endocrinol. 2007 Mar;156(3):341-51. doi: 10.1530/EJE-06-0598.
- Derived from this study: PubMed 21963127Krusenstjerna-Hafstrom T, Rasmussen MH, Raschke M, Govender S, Madsen J, Christiansen JS. Biochemical markers of bone turnover in tibia fracture patients randomly assigned to growth hormone (GH) or placebo injections: Implications for detection of GH abuse. Growth Horm IGF Res. 2011 Dec;21(6):331-5. doi: 10.1016/j.ghir.2011.08.003. Epub 2011 Oct 1.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
40 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing somatropin in people with Bone Fracture and Tibia Fractures, run by Novo Nordisk A/S at 40 sites in 9 countries.
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 4 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: finished, as of the sponsor's last update on 23 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Germany, Hungary, Israel, Poland, South Africa and 4 more countries. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time from surgery until fracture has healed (time frame: During a 12 month period). 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 NCT00254514, 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 23 Jan 2017.