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Trial record 35 of 127 for:    Recruiting, Not yet recruiting, Available Studies | "Hip Injuries"

The Effect of Teriparatide on Bone Union in Unstable Intertrochanteric Fracture Patients Treated With PFNA

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ClinicalTrials.gov Identifier: NCT03133195
Recruitment Status : Not yet recruiting
First Posted : April 28, 2017
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Prof.Dr.Aree Tanavalee, M.D., King Chulalongkorn Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Unstable Intertrochanteric Fracture Drug: Teriparatide Drug: Placebo Dietary Supplement: Calcium supplement Dietary Supplement: Vitamin D Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The patients will be randomized in 1:1 ratio to receive Teriparatide or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double blind, placebo-controlled
Primary Purpose: Treatment
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)
Estimated Study Start Date : May 17, 2017
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Experimental: Teriparatide
Teriparatide 20 μg subcutaneous once daily for 12 weeks
Drug: Teriparatide
Teriparatide 20 μg subcutaneous once daily for 12 weeks (Patient self administration at home by pen injector)
Other Name: r-Human parathyroid hormone

Dietary Supplement: Calcium supplement
1000 mg/day of elemental calcium

Dietary Supplement: Vitamin D
20,000 IU/week of vitamin D2

Placebo Comparator: Placebo
Placebo subcutaneous once daily for 12 weeks
Drug: Placebo
Placebo subcutaneous once daily for 12 weeks. (Patient self administration at home by pen injector)

Dietary Supplement: Calcium supplement
1000 mg/day of elemental calcium

Dietary Supplement: Vitamin D
20,000 IU/week of vitamin D2




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Clinical evidence of healing assessed by Harris Hip Score as one of functional outcomes [ Time Frame: from randomization, assessed up to 24 months ]
    Harris Hip Score (90-100: Excellent, 80-89: Good, 70-79: Fair, <70 poor)

  2. Clinical evidence of healing assessed by weight bearing ability as one of functional outcomes [ Time Frame: from randomization, assessed up to 24 months ]
    Weight bearing ability (Non weight bearing, Partial weight bearing, Full weight bearing)

  3. Clinical evidence of healing assessed by walking ability as one of functional outcomes [ Time Frame: from randomization, assessed up to 24 months ]
    Walking ability (Independent walking, Assisted walking, Bedridden)



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female patient, age ≥ 50 years at the time of screening
  2. Unstable intertrochanteric fracture (AO/OTA 31-A2 and 31-A3)
  3. Treated by proximal femoral nail antirotation (PFNA)

Exclusion Criteria:

  1. Known hypersentivity to teriparatide or any form of PTH or analogue
  2. Metabolic bone disease other than primary osteoporosis (including Hyper Parathyroidism and Paget's disease of bone)
  3. Increased baseline risk of osteosarcoma (Paget's disease of the bone, previous primary skeletal malignancy, or skeletal exposure to therapeutic irradiation)
  4. 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.
  5. Pre-existing of hypercalcemia (total serum calcium >10.5 mg/dL or 2.6 mmol/L)
  6. Abnormally elevated serum intact parathyroid hormone at screening (serum PTH > 70 pg/mL)
  7. Severe vitamin D deficiency (25-hydroxyvitamin D < 12 ng/mL)
  8. Unexplained elevations of alkaline phosphatase (ALP > 120 UL)
  9. Severe renal impairment (CrCL < 30 mL/min)
  10. Current treatment with digoxin and necessary to continue use during the study
  11. 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)
  12. 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.
  13. Previous treatment with teriparatide, PTH or other PTH analogs, or prior participation in any other clinical trial studying teriparatide, PTH or other PTH analogs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133195


Contacts
Contact: Prof. Dr. Aree Tanavalee, M.D. +662 5664212 areetang@orthochula.com

Sponsors and Collaborators
King Chulalongkorn Memorial Hospital
Investigators
Principal Investigator: Prof.Dr.Aree Tanavalee, M.D. Chulalongkorn University

Responsible Party: Prof.Dr.Aree Tanavalee, M.D., Prof. Dr., M.D., King Chulalongkorn Memorial Hospital
ClinicalTrials.gov Identifier: NCT03133195     History of Changes
Other Study ID Numbers: ORTHCU-2017-01
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof.Dr.Aree Tanavalee, M.D., King Chulalongkorn Memorial Hospital:
Terriparatide, bone fracture healing, PFNA

Additional relevant MeSH terms:
Hip Injuries
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Leg Injuries
Vitamins
Vitamin D
Teriparatide
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents