Unstable Intertrochanteric FracturePhase 3NCT03133195
The Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With PFNA
A Phase 3 study testing Teriparatide, Calcium supplement and Vitamin D in people with Unstable Intertrochanteric Fracture and Pertrochanteric Fracture of Femur, Closed, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by radiographic and clinical outcomes. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Unstable Intertrochanteric Fracture, Pertrochanteric Fracture of Femur, Closed
- What is being tested?
- Teriparatide, Calcium supplement and Vitamin D
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 17 May 2017to 1 Jul 2023
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patient, age ≥ 50 years at the time of screening
- Unstable intertrochanteric fracture (AO/OTA 31-A2 and 31-A3)
- Treated by proximal femoral nail antirotation (PFNA)
Who cannot join
- Known hypersentivity to teriparatide or any form of PTH or analogue
- Metabolic bone disease other than primary osteoporosis (including Hyper Parathyroidism and Paget's disease of bone)
- Increased baseline risk of osteosarcoma (Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation)
- History of malignant neoplasm in the 5 years prior to the study (with the exception of superficial basal cell carcinoma or squamous cell carcinoma) and carcinoma in situ of the uterine cervix treated less than 1 year prior to the study.
- Pre-existing of hypercalcemia (total serum calcium >10.5 mg/dL or 2.6 mmol/L)
- Abnormally elevated serum intact parathyroid hormone at screening (serum PTH > 70 pg/mL)
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- Severe vitamin D deficiency (25-hydroxyvitamin D < 12 ng/mL)
- Unexplained elevations of alkaline phosphatase (ALP > 120 UL)
- Severe renal impairment (CrCL < 30 mL/min)
- Current treatment with digoxin and necessary to continue use during the study
- Concurrent treatment with oral bisphosphonates, selective estrogen receptor modulator (SERMs), calcitonin, estrogen (oral, transdermal, or injection), progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and active vitamin D3 analogs. (Previous treatment is allowed but must be discontinued at screening)
- Previous treatment with strontium ranelate for any duration, intravenous bisphophonates within 12 months prior to the screening date, and/or denosumab within 6 months prior to the screening.
- Previous treatment with teriparatide, PTH or other PTH analogs, or prior participation in any other clinical trial studying teriparatide, PTH or other PTH analogs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With Proximal Femoral Nail Antirotation (PFNA)
Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by radiographic and clinical outcomes.
Read the detailed description
Patients will undergo screening assessment to determine the eligibility for study participation and will be randomized in 1:1 ratio to receive Teriparatide 20 μg or placebo subcutaneous once daily for 12 weeks.
All patients will receive supplements of 1000 mg/day of elemental calcium and 20,000 IU/week of vitamin D2.
Patients will be scheduled to clinic visit for radiographic and clinical assessment at 2, 6,12 and 24 weeks postoperatively. Each participant will be in the study for 6 months in total.
- Being tested
- Teriparatide, Placebo, Calcium supplement, Vitamin D
- Keywords
- Terriparatide, bone fracture healing, PFNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called r-Human parathyroid hormone
Teriparatide 20 μg subcutaneous once daily for 12 weeks (Patient self administration at home by pen injector)
PlaceboDrug
Placebo subcutaneous once daily for 12 weeks. (Patient self administration at home by pen injector)
Calcium supplementDietary supplement
1000 mg/day of elemental calcium
Vitamin DDietary supplement
20,000 IU/week of vitamin D2
| Study group | Role | What they receive |
|---|---|---|
| Teriparatide | Experimental | Teriparatide 20 μg subcutaneous once daily for 12 weeks Receives: Drug: Teriparatide; Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D |
| Placebo | Placebo comparator | Placebo subcutaneous once daily for 12 weeks Receives: Drug: Placebo; Dietary Supplement: Calcium supplement; Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to healing assessed by radiographic evidence
Fracture is judged to be healed radiographically if bridging callus was evident on 3 of 4 cortices as seen on two views (cortical bridging of three cortices)
Measured: from randomization, assessed up to 24 months
Secondary outcomes (3)
Clinical evidence of healing assessed by Harris Hip Score as one of functional outcomes
Harris Hip Score (90-100: Excellent, 80-89: Good, 70-79: Fair, <70 poor)
Measured: from randomization, assessed up to 24 months
Clinical evidence of healing assessed by weight bearing ability as one of functional outcomes
Weight bearing ability (Non weight bearing, Partial weight bearing, Full weight bearing)
Measured: from randomization, assessed up to 24 months
Clinical evidence of healing assessed by walking ability as one of functional outcomes
Walking ability (Independent walking, Assisted walking, Bedridden)
Measured: from randomization, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start17 May 2017
- Primary completion1 Jun 2022
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable Intertrochanteric FractureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomized in 1:1 ratio to receive Teriparatide or placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.Dr.Aree Tanavalee, M.D., King Chulalongkorn Memorial Hospital
- Investigators
- Prof.Dr.Aree Tanavalee, M.D., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133195
- Sponsor's protocol ID
- ORTHCU-2017-01
- Status last verified
- Jan 2025
- First submitted
- 21 Apr 2017
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With Proximal Femoral Nail Antirotation (PFNA)
- ClinicalTrials.gov ID
- NCT03133195
- Acronym / sponsor ID
- ORTHCU-2017-01
- Keywords
- Terriparatide, bone fracture healing, PFNA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Study start
- 17 May 2017 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 28 Apr 2017 (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.
Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by radiographic and clinical outcomes.
Detailed description
Patients will undergo screening assessment to determine the eligibility for study participation and will be randomized in 1:1 ratio to receive Teriparatide 20 μg or placebo subcutaneous once daily for 12 weeks.
All patients will receive supplements of 1000 mg/day of elemental calcium and 20,000 IU/week of vitamin D2.
Patients will be scheduled to clinic visit for radiographic and clinical assessment at 2, 6,12 and 24 weeks postoperatively. Each participant will be in the study for 6 months in total.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients will be randomized in 1:1 ratio to receive Teriparatide or placebo
| Arm | Type | Receives |
|---|---|---|
| Teriparatide | Experimental | Drug: Teriparatide, Dietary Supplement: Calcium supplement, Dietary Supplement: Vitamin DTeriparatide 20 μg subcutaneous once daily for 12 weeks |
| Placebo | Placebo comparator | Drug: Placebo, Dietary Supplement: Calcium supplement, Dietary Supplement: Vitamin DPlacebo subcutaneous once daily for 12 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female patient, age ≥ 50 years at the time of screening
- Unstable intertrochanteric fracture (AO/OTA 31-A2 and 31-A3)
- Treated by proximal femoral nail antirotation (PFNA)
Key exclusion criteria (13 listed)
- Known hypersentivity to teriparatide or any form of PTH or analogue
- Metabolic bone disease other than primary osteoporosis (including Hyper Parathyroidism and Paget's disease of bone)
- Increased baseline risk of osteosarcoma (Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation)
- History of malignant neoplasm in the 5 years prior to the study (with the exception of superficial basal cell carcinoma or squamous cell carcinoma) and carcinoma in situ of the uterine cervix treated less than 1 year prior to the study.
- Pre-existing of hypercalcemia (total serum calcium >10.5 mg/dL or 2.6 mmol/L)
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 |
|---|---|---|
| TeriparatideAlso: r-Human parathyroid hormoneTeriparatide 20 μg subcutaneous once daily for 12 weeks (Patient self administration at home by pen injector) | Drug | Teriparatide |
| PlaceboPlacebo subcutaneous once daily for 12 weeks. (Patient self administration at home by pen injector) | Drug | Placebo |
| Calcium supplement1000 mg/day of elemental calcium | Dietary supplement | Placebo, Teriparatide |
| Vitamin D20,000 IU/week of vitamin D2 | Dietary supplement | Placebo, Teriparatide |
Primary outcome
Time to healing assessed by radiographic evidence
Time frame: from randomization, assessed up to 24 months
Fracture is judged to be healed radiographically if bridging callus was evident on 3 of 4 cortices as seen on two views (cortical bridging of three cortices)
3 secondary outcomes
Clinical evidence of healing assessed by Harris Hip Score as one of functional outcomes
Time frame: from randomization, assessed up to 24 months
Clinical evidence of healing assessed by weight bearing ability as one of functional outcomes
Time frame: from randomization, assessed up to 24 months
Clinical evidence of healing assessed by walking ability as one of functional outcomes
Time frame: from randomization, assessed up to 24 months
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 15 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Unstable Intertrochanteric Fracture
Recruiting
InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery
Fracture of Hip
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.
Prof.Dr.Aree Tanavalee, M.D. principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Teriparatide, Calcium supplement and Vitamin D in people with Unstable Intertrochanteric Fracture and Pertrochanteric Fracture of Femur, Closed, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
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 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: finished, as of the sponsor's last update on 15 Jan 2025. 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 Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 to healing assessed by radiographic evidence (time frame: from randomization, assessed up to 24 months). 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 15 Jan 2025.