Primary outcomeCount of participants· 3 months
Number of Participants With Evidence of Cortical Bridging for Fracture Healing
| Group | Value (Participants) |
|---|---|
| Teriparatide | 9 |
| Placebo | 8 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataPTH(1-34) and Pelvic Fracture Healing - a Randomized Controlled Trial
NCTNCT02972424 (opens ClinicalTrials.gov in a new tab)Other id2015-330
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 35 participants (actual)
- Sponsor
- Hospital for Special Surgery, New York · Other
- Design
- Randomized · Quadruple masking
- Countries
1 country
United States
- Start
- 1 May 2017
- Primary completion
- 8 Mar 2021
- Completion
- 8 Jul 2021
- First posted
- 23 Nov 2016 (estimated)
- Last update posted
- 27 Jul 2022
- Conditions
- Osteoporotic Fractures
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201720182019202020212022
- Ph 2
PTH(1-34) and Pelvic Fracture Healing - a Randomized Controlled Trial
NCT029724241 May 2017 to 8 Jul 2021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
In the proposed trial the investigators will recruit women and men \>65 years of age with acute osteoporosis-related pelvic fractures and address 3 specific aims over 3 months of treatment in a placebo controlled double blind study to determine if standard care and teriparatide 20 mcg/day versus placebo for pelvic fractures: 1. Results in earlier evidence of cortical bridging on routine radiographs followed by confirmatory Focus CT, a novel method to reduce radiation exposure from CT scans (primary outcome). 2. Leads to a faster reduction in pain as assessed by both the Numeric Rating Scale and a reduction in the use of narcotics (secondary outcome). 3. Leads more rapidly to improved functional outcome using a short physical performance battery to assess lower extremity function (secondary outcome).
Interventions
- Teriparatide Prefilled SyringeDrug
- PlaceboDrug
Arms2
Experimental
Teriparatide Prefilled Syringe
TPTD is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable delivery device (pen) for subcutaneous injection. Each prefilled delivery device is filled with 2.7 mL to deliver 2.4 mL. Each mL contains 250 mcg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetic acid, 0.1 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3 mg Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4.
Placebo comparator
Placebo
Placebo is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable delivery device (pen) for subcutaneous injection. Each prefilled delivery device is filled with 2.7 mL to deliver 2.4 mL. Each mL contains 0.41 mg glacial acetic acid, 0.1 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3 mg Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4.
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of Participants With Evidence of Cortical Bridging for Fracture Healing
Time frame · 3 months
Registry description
Evidence of cortical bridging based on Focus CT,
Secondary outcomes(4)
Change in Pain by Numeric Rating Scale Between Baseline and Three Months
Time frame · 3 months
Registry description
Leads to a faster reduction in pain as assessed by the Numeric Rating Scale of 0 (no pain) to 10 (worst pain). The mean reduction in pain score from 0 to 3 months is reported. Higher scores mean a greater reduction in pain.
Functional Outcome Using a Battery That Includes Walking Speed, Repeated Chair Stands, and Balance at 3 Months
Time frame · 3 months
Registry description
More rapidly improved functional outcome using a short physical performance battery to assess lower extremity function (walking speed, repeated chair stands, and balance) at 3 months. Scale is 0 to 100 with higher scores indicating better physical performance.
Physical Function at 12 Months Using a Battery That Includes Walking Speed, Repeated Chair Stands, and Balance
Time frame · 12 months
Registry description
More rapidly improved functional outcome using a short physical performance battery to assess lower extremity function (walking speed, repeated chair stands, and balance) at 12 months. Scale is 0 to 100 with higher scores indicating better performance.
Pain at 12 Months Based on the Numeric Rating Scale
Time frame · 12 months
Registry description
Pain at 12 months as assessed by the Numeric Rating Scale (0 to 10 where 0 means no pain and 10 worst pain)
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(4)
Secondary outcomeMean· 3 months
Change in Pain by Numeric Rating Scale Between Baseline and Three Months
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Teriparatide | 1.94 | 3.42 |
| Placebo | 2.78 | 3.14 |
Secondary outcomeMean· 3 months
Functional Outcome Using a Battery That Includes Walking Speed, Repeated Chair Stands, and Balance at 3 Months
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Teriparatide | 74.2 | 3.6 |
| Placebo | 59.9 | 4.7 |
Secondary outcomeMean· 12 months
Physical Function at 12 Months Using a Battery That Includes Walking Speed, Repeated Chair Stands, and Balance
| Group | Value (score on a scale 0-100) | Spread |
|---|---|---|
| Teriparatide | 70.0 | 3.3 |
| Placebo | 64.9 | 4.1 |
Secondary outcomeMean· 12 months
Pain at 12 Months Based on the Numeric Rating Scale
| Group | Value (score on a scale) | Spread |
|---|---|---|
| Teriparatide | 1.5 | 0.4 |
| Placebo | 1.9 | 0.6 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Teriparatide for 3 Months Then Open Label for 9 MonthsTPTD is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable delivery device (pen) for subcutaneous injection. Each prefilled delivery device is filled with 2.7 mL to deliver 2.4 mL. Each mL contains 250 mcg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetic acid, 0.1 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3 mg Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4. Teriparatide Prefilled Syringe: TPTD 20 mcg | 1 / 18 | 4 / 18 | 12 / 18 |
| Placebo for 3 MonthsPlacebo is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable delivery device (pen) for subcutaneous injection. Each prefilled delivery device is filled with 2.7 mL to deliver 2.4 mL. Each mL contains 0.41 mg glacial acetic acid, 0.1 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3 mg Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4. Placebo: Matching placebo as a prefilled syringe with all inactive ingredients | 0 / 17 | 1 / 17 | 4 / 17 |
| Open Label Teriparatide Following PlaceboTPTD is supplied as a sterile, colorless, clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable delivery device (pen) for subcutaneous injection. Each prefilled delivery device is filled with 2.7 mL to deliver 2.4 mL. Each mL contains 250 mcg teriparatide (corrected for acetate, chloride, and water content), 0.41 mg glacial acetic acid, 0.1 mg sodium acetate (anhydrous), 45.4 mg mannitol, 3 mg Metacresol, and Water for Injection. In addition, hydrochloric acid solution 10% and/or sodium hydroxide solution 10% may have been added to adjust the product to pH 4. Teriparatide Prefilled Syringe: TPTD 20 mcg | 0 / 12 | 3 / 12 | 7 / 12 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies1
Studies that cite this trial.
Studies with results
1 study on this page
Indexing hint: Randomized controlled trial · 2022
5 results
Teriparatide and pelvic fracture healing: a phase 2 randomized controlled trial.
Nieves et al. 2022Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USAcited by 18
PMID 34383100PMC8758515DOI 10.1007/s00198-021-06065-4PUB-34383100
Rights unknown5 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
Postmenopausal women and men \>65 years of age with acute pelvic fractures, occurring with minimal trauma, presenting to Helen Hayes Hospital, Hospital for Special Surgery, or New York Hospital (Cornell Medical). Patients that have either one or multiple pelvic fractures or sacral and pelvic fractures will be included in the study. Subjects must start treatment within one month of hip fracture.
Exclusion Criteria:
1. Persons unable to complete the NRS and other surveys based on their mini-mental status score (≤18; consistent with moderate and severe cognitive impairment)
2. Previously (prior to fracture) non-ambulatory subjects
3. Exclusion criteria related to contraindication or intolerance to TPTD:
1. Hypersensitivity to TPTD
2. Patients with increased risk of osteosarcoma: Paget's disease, history of radiation exposure
3. Patients with active hypercalcemia
4. Current hyperparathyroidism and other metabolic bone disease including osteogenesis imperfecta
5. History of multiple renal calculi or renal calculus within the last 2 years
6. Normal alkaline phosphatase levels will not be used as an entrance criterion because most fracture patients will have elevations due to the acute fracture. However, the investigators will attempt to obtain lab tests from the period prior to fracture to determine if they were normal. If unexplained elevations in alkaline phosphatase are found in labs prior to the fracture we will exclude that subject.
7. Evidence of metastatic cancer or history of bone cancer or any active cancer other than basal or squamous cell carcinoma.
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