Hip FracturePhase 2SHIFTNCT00787358
A Proof-of-Concept Study Investigating the Safety and Efficacy of ZT-031 on Hip Fracture Healing in Men and Postmenopausal Women
A Phase 2 study testing ZT-031 in people with Hip Fracture, run by Zelos Therapeutics at 1 site in United States.
Trial 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 better or faster following surgery and to determine if ZT-031 is safe for patients with fractures. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Hip Fracture
- What is being tested?
- ZT-031
- 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 siteUnited States
- Study dates
- Dec 2008to Jul 2009
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Proof-of-Concept Study Investigating the Safety and Efficacy of ZT-031 on Hip Fracture Healing in Men and Postmenopausal Women With Intertrochanteric Fracture of the Hip
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 better or faster following surgery and to determine if ZT-031 is safe for patients with fractures. To be allowed in the study you have to have a type of hip fracture that requires surgery that is being studied (intertrochanteric fracture). You must also otherwise be in good health, with no serious diseases such as cancer, neurologic disease, other bone disease, liver, heart or kidney disease. You must be able to inject yourself every day with the study medication using an injection pen, like that used for insulin injections.
- Conditions
- Hip Fracture
- Being tested
- ZT-031, placebo
- Keywords
- osteoporosis, intertrochanteric, hip fracture, compression hip screw, surgical fixation
- Medical subject headings
- Hip Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZT-031Drug
80 ul subcutaneous injection per day
placeboOther
80 ul daily subcutaneous injection of vehicle only
| Study group | Role | What they receive |
|---|---|---|
| ZT-031 | Active comparator | Not described Receives: Drug: ZT-031 |
| Placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compression hip screw (CHS) migration: the difference in the tip apex distance (TAD) post-operatively to that at Visit 7/Week 16
Measured: 16 weeks
Secondary outcomes (4)
Screw barrel impaction distance
Measured: 16 weeks
Screw cut-out and/or other hardware failure
Measured: 16 weeks
Incidence of fracture non-union
Measured: 16 weeks
Need for surgical revision with or without hardware removal
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2009 (estimated)
- Study completionJul 2009 (estimated)
Why it stopped: Change in company direction
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zelos Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787358
- Sponsor's protocol ID
- OC-018
- Acronym
- SHIFT
- Status last verified
- Jun 2009
- First submitted
- 6 Nov 2008
- Last updated
- 4 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Proof-of-Concept Study Investigating the Safety and Efficacy of ZT-031 on Hip Fracture Healing in Men and Postmenopausal Women With Intertrochanteric Fracture of the Hip
- ClinicalTrials.gov ID
- NCT00787358
- Acronym / sponsor ID
- SHIFT / OC-018
- Conditions
- Hip Fracture
- Keywords
- osteoporosis, intertrochanteric, hip fracture, compression hip screw, surgical fixation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in company direction
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zelos TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 7 Nov 2008 (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.
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 better or faster following surgery and to determine if ZT-031 is safe for patients with fractures. To be allowed in the study you have to have a type of hip fracture that requires surgery that is being studied (intertrochanteric fracture). You must also otherwise be in good health, with no serious diseases such as cancer, neurologic disease, other bone disease, liver, heart or kidney disease. You must be able to inject yourself every day with the study medication using an injection pen, like that used for insulin injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZT-031 | Active comparator | Drug: ZT-031 |
| Placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (36 listed)
- 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.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ZT-03180 ul subcutaneous injection per day | Drug | ZT-031 |
| placebo80 ul daily subcutaneous injection of vehicle only | Other | Placebo |
Primary outcome
Compression hip screw (CHS) migration: the difference in the tip apex distance (TAD) post-operatively to that at Visit 7/Week 16
Time frame: 16 weeks
4 secondary outcomes
Screw barrel impaction distance
Time frame: 16 weeks
Screw cut-out and/or other hardware failure
Time frame: 16 weeks
Incidence of fracture non-union
Time frame: 16 weeks
Need for surgical revision with or without hardware removal
Time frame: 16 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2009.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZT-031 in people with Hip Fracture, run by Zelos Therapeutics at 1 site in United States.
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 36 inclusion and 0 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: withdrawn, as of the sponsor's last update on 4 Jun 2009. 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 United States. 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 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 was withdrawn before enrolling participants, so there are no results.
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?
Compression hip screw (CHS) migration: the difference in the tip apex distance (TAD) post-operatively to that at Visit 7/Week 16 (time frame: 16 weeks). 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 4 Jun 2009.