Colles' FracturePhase 2NCT04473989
Weekly Use of Teriparatide to Accelerate Healing of Distal Radius Fracture
A Phase 2 study testing recombinant teriparatide for injection in people with Colles' Fracture, run by Peking University Third Hospital.
Trial summary
The purpose of this study is to examine the effect of weekly dosing strategy on fracture healing. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colles' Fracture
- What is being tested?
- recombinant teriparatide for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Jun 2024
- 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 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Postmenopausal women aged 45-75 (at least 2 years after menopause)
- With primary osteoporosis
- Patients with Colles fractures with a fracture time of no more than 7 days
- conservative treatment after fracture (closed reduction and immobilization)
- no multiple fractures
- Informed well and agree to participate in this clinical trial
Who cannot join
- Combine other physical diseases, including diabetes, severe hypertension, autoimmune diseases, heart, liver and kidney diseases, malignant tumors, mental illnesses, and other diseases that doctors believe may affect the healing process.
- In addition to primary osteoporosis, any disease affecting bone metabolism or treatment response, including serum PTH>65pg/ml, 25-hydroxyvitamin D<20ng/ml, alkaline phosphatase>135U/L, history of bone tumor, Paget disease, history of radiotherapy
- The fracture site has a history of trauma or surgery, affecting the function of the wrist or forearm
- Those who are allergic to PTH or any excipients
- Currently receiving anti-osteoporosis treatment or receiving other anti-osteoporosis treatment during the trial
- Contraindication of teriparatide including hyperparathyroidism, severe renal insufficiency, hypercalcemia, etc.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Weekly Injection of Teriparatide on the Healing of Distal Radius Fracture in a Double-blind, Randomized Controlled Clinical Trial
The purpose of this study is to examine the effect of weekly dosing strategy on fracture healing.
- Conditions
- Colles' Fracture
- Being tested
- recombinant teriparatide for injection, Placebo
- Medical subject headings
- Colles' Fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant teriparatide for injectionDrug
Also called Xinfutai
weekly subcutaneous administration of 40 ug
PlaceboDrug
Also called Xinfutai placebo
weekly subcutaneous administration of 40 ug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Injection product without active teriparatide Receives: Drug: Placebo |
| PTH 40ug/w | Experimental | Injection product with active teriparatide Receives: Drug: recombinant teriparatide for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The median time of radiographic healing
A score of 13 by Modified Radiographic Union Scale for Tibia fractures (mRUST) scoring system would provide a confident assessment of union
Measured: 0-14 weeks
Secondary outcomes (2)
Patient-Rated Wrist Evaluation
A 15-item questionnaire(PRWE) that rates wrist-related pain and disability in functional activities. The scores range from 0 (no disability) to 100 (severest disability).
Measured: 0, 4, 6, 8, 10, 12, 14 and 16 weeks
Grip strength
Grip strength will be assessed by a dynamometer.
Measured: 6, 8, 10, 12, 14, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start1 Jun 2021 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colles' FractureStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunli Song, M.D.; Ph. D., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473989
- Sponsor's protocol ID
- M2020207
- Status last verified
- Jun 2020
- First submitted
- 12 Jul 2020
- Last updated
- 16 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 19594305Ebata S, Takahashi J, Hasegawa T, Mukaiyama K, Isogai Y, Ohba T, Shibata Y, Ojima T, Yamagata Z, Matsuyama Y, Haro H. Role of Weekly Teriparatide Administration in Osseous Union Enhancement within Six Months After Posterior or Transforaminal Lumbar Interbody Fusion for Osteoporosis-Associated Lumbar Degenerative Disorders: A Multicenter, Prospective Randomized Study. J Bone Joint Surg Am. 2017 Mar 1;99(5):365-372. doi: 10.2106/JBJS.16.00230.
PubMed 28244906Zhang W, Zhu J, Ma T, Liu C, Hai B, Du G, Wang H, Li N, Leng H, Xu Y, Song C. Comparison of the effects of once-weekly and once-daily rhPTH (1-34) injections on promoting fracture healing in rodents. J Orthop Res. 2018 Apr;36(4):1145-1152. doi: 10.1002/jor.23750. Epub 2017 Nov 20.
PubMed 28960481Zhu J, Zhang C, Jia J, Yuan W, Zhang M, Leng H, Song C. Effect of weekly teriparatide injections on osteoporotic fracture healing: protocol for a double-blind, randomised controlled trial. BMJ Open. 2021 Apr 1;11(4):e043137. doi: 10.1136/bmjopen-2020-043137.
PubMed 33795297
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Weekly Injection of Teriparatide on the Healing of Distal Radius Fracture in a Double-blind, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04473989
- Acronym / sponsor ID
- M2020207
- Conditions
- Colles' Fracture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 16 Jul 2020 (actual)
- 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 this study is to examine the effect of weekly dosing strategy on fracture healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboInjection product without active teriparatide |
| PTH 40ug/w | Experimental | Drug: recombinant teriparatide for injectionInjection product with active teriparatide |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Postmenopausal women aged 45-75 (at least 2 years after menopause)
- With primary osteoporosis
- Patients with Colles fractures with a fracture time of no more than 7 days
- conservative treatment after fracture (closed reduction and immobilization)
- no multiple fractures
Key exclusion criteria (6 listed)
- Combine other physical diseases, including diabetes, severe hypertension, autoimmune diseases, heart, liver and kidney diseases, malignant tumors, mental illnesses, and other diseases that doctors believe may affect the healing process.
- In addition to primary osteoporosis, any disease affecting bone metabolism or treatment response, including serum PTH>65pg/ml, 25-hydroxyvitamin D<20ng/ml, alkaline phosphatase>135U/L, history of bone tumor, Paget disease, history of radiotherapy
- The fracture site has a history of trauma or surgery, affecting the function of the wrist or forearm
- Those who are allergic to PTH or any excipients
- Currently receiving anti-osteoporosis treatment or receiving other anti-osteoporosis treatment during the trial
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 |
|---|---|---|
| recombinant teriparatide for injectionAlso: Xinfutaiweekly subcutaneous administration of 40 ug | Drug | PTH 40ug/w |
| PlaceboAlso: Xinfutai placeboweekly subcutaneous administration of 40 ug | Drug | Placebo |
Primary outcome
The median time of radiographic healing
Time frame: 0-14 weeks
A score of 13 by Modified Radiographic Union Scale for Tibia fractures (mRUST) scoring system would provide a confident assessment of union
2 secondary outcomes
Patient-Rated Wrist Evaluation
Time frame: 0, 4, 6, 8, 10, 12, 14 and 16 weeks
Grip strength
Time frame: 6, 8, 10, 12, 14, and 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- 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 28244906Ebata S, Takahashi J, Hasegawa T, Mukaiyama K, Isogai Y, Ohba T, Shibata Y, Ojima T, Yamagata Z, Matsuyama Y, Haro H. Role of Weekly Teriparatide Administration in Osseous Union Enhancement within Six Months After Posterior or Transforaminal Lumbar Interbody Fusion for Osteoporosis-Associated Lumbar Degenerative Disorders: A Multicenter, Prospective Randomized Study. J Bone Joint Surg Am. 2017 Mar 1;99(5):365-372. doi: 10.2106/JBJS.16.00230.
- Background: PubMed 28960481Zhang W, Zhu J, Ma T, Liu C, Hai B, Du G, Wang H, Li N, Leng H, Xu Y, Song C. Comparison of the effects of once-weekly and once-daily rhPTH (1-34) injections on promoting fracture healing in rodents. J Orthop Res. 2018 Apr;36(4):1145-1152. doi: 10.1002/jor.23750. Epub 2017 Nov 20.
- Derived from this study: PubMed 33795297Zhu J, Zhang C, Jia J, Yuan W, Zhang M, Leng H, Song C. Effect of weekly teriparatide injections on osteoporotic fracture healing: protocol for a double-blind, randomised controlled trial. BMJ Open. 2021 Apr 1;11(4):e043137. doi: 10.1136/bmjopen-2020-043137.
- Individual participant dataSharing planned: No
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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.
Chunli Song, M.D.; Ph. D. principal investigator
Peking University Third Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing recombinant teriparatide for injection in people with Colles' Fracture, run by Peking University Third Hospital.
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 6 inclusion and 6 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 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junxiong Zhu, M.D. (+86 18801238160, zhujunxiong@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The median time of radiographic healing (time frame: 0-14 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 NCT04473989, which also lists 4 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 16 Jul 2020.