Status:
WITHDRAWN
A Proof-of-Concept Study Investigating the Safety and Efficacy of ZT-031 on Hip Fracture Healing in Men and Postmenopausal Women
Lead Sponsor:
Zelos Therapeutics
Conditions:
Hip Fracture
Eligibility:
All Genders
30+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to test if an experimental drug called ZT-031 can help men over 30 years or post-menopausal women over 55 years of age with certain types of hip fracture to heal ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Subjects are required to meet all of the following criteria for inclusion in the study:
- Signed Institutional Review Board (IRB)/Research Ethics Board (REB)-approved informed consent form (ICF).
- Sustained an unstable low energy intertrochanteric (Evans Type II or higher) hip fracture within 7 days prior to planned surgery date. Low energy is defined as a fracture that occurs spontaneously or from a fall from a stationary height of ≤ 1 meter (3 feet) or missing one to three steps.
- Women ≥ 55 years of age and men ≥ 30 years of age of any race. If female, subjects must be post-menopausal for at least 5 years and weigh ≥ 110 lbs or 50 kg.
- Subjects who are expected to undergo or have recently undergone (within two weeks) open or closed repair of the fracture requiring a CHS.
- By history, the subject was at least household ambulatory prior to hip fracture.
- Serum calcium level within the normal range when corrected for albumin. Corrected calcium (mg/dL) = Serum Ca (mg/dL) + 0.8 x (4.0 - albumin \[g/dL\])
- Able and willing to comply with all protocol procedures.
- Cognitive, visual, auditory and physical abilities adequate to undertake assessments.
- Availability of a care partner to administer injections or demonstrated ability to self-administer injections. Subjects planning to self-administer study drug will need to show that they will be capable of accurately self-injecting study drug in rotating quadrants of the abdomen, in the opinion of the Investigator.
- Clinically acceptable medical history and physical examination, according to the judgment of the Investigator.
- Laboratory results within normal ranges or, if abnormal, considered by the Investigator as not clinically significant for the well-being of the subject or for the purpose of the study.
- The following additional criteria are required for randomization and dosing with ZT-031 or placebo to occur:
- The most recent value for 25-hydroxy Vitamin D (25OHD) must be at or above the lower limit of normal (LLN) for the laboratory reference range of the testing method used for determination of 25OHD. NOTE: Randomization should be delayed until it is known that 25OHD is ≥ LLN.
- The most recent value for intact PTH must be ≤ ULN for the laboratory reference range.
- Randomization and dosing must occur within 2 weeks post-op. Exclusion Criteria
- Subjects who meet any of the following conditions are excluded from this clinical study:
- Previous fracture(s) or bone or joint surgery in the currently fractured site
- Intertrochanteric fracture with reverse obliquity
- Pathologic fracture: A fracture occurring at a site of metabolic bone disease (other than osteoporosis) or a benign or malignant tumor
- Presence of a concurrent disease known to affect bone metabolism other than post-menopausal osteoporosis, including but not limited to hyperparathyroidism, hyperthyroidism, osteogenesis imperfecta, abnormalities of serum calcium, Paget's disease, or osteomalacia
- History of rheumatoid arthritis
- Any significant neurologic disease including but not limited to any dementing illness or other neurodegenerative disease, cerebrovascular disease, epilepsy or undiagnosed syncope
- Unstable or clinically significant cardiovascular disease resulting in:
- Hemodynamic instability manifested as hypotension unresponsive to intravenous fluids
- Uncontrolled hypertension requiring administration of parenteral therapy.
- Renal disease, defined by:
- Creatinine level of \>2.0 mg/dL
- Urolithiasis or nephrolithiasis in the last 2 years
- Hepatic disease or insufficiency, defined by liver function tests (ALT, AST or GGT) \> 3 times the ULN or bilirubin \> 34 mmol/L or 2.0 mg/dL
- Currently receiving treatment for cancer
- History of external beam radiation to the skeleton or a radiation therapy implant device
- Presence of substance abuse, including alcohol, within 1 year of Screening
- Current or previous use of any PTH compound, including ZT-031
- Use of any investigational compound within 4 weeks of Screening, or within 5 half-lives of compound, whichever is longer
- Use of any bone substitutes, osteobiologics or any fracture healing drug.
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00787358
Start Date
December 1 2008
End Date
July 1 2009
Last Update
June 4 2009
Active Locations (1)
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1
J. Edward Puzas
Rochester, New York, United States, 14642