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Effect of Teriparatide on Hip Fracture Healing

10 april 2015 bijgewerkt door: Eli Lilly and Company

Effect of Teriparatide on Femoral Neck Fracture Healing

The purpose of this study is to see whether teriparatide, given for 6 months versus placebo, will improve the healing of hip (femoral neck) fractures that are repaired during surgery using certain types of orthopedic screws. The study will enroll men and postmenopausal women at least 50 years of age with a recent hip (femoral neck) fracture caused by low-trauma (for example, fall from standing height or less).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This is a 12-month, Phase 3, prospective, randomized, parallel, double-blind, placebo-controlled, multicenter, multinational study to evaluate the effect of 6 months of treatment with teriparatide on fracture healing in participants who have sustained a recent low-trauma, unilateral, femoral neck fracture stabilized by internal fixation. The study has 3 periods:

  1. A screening period that must be completed in ≤ 14 days after operative treatment of the femoral neck fracture
  2. A 6-month double-blind treatment period [teriparatide 20 µg or placebo given once daily by SC injection]
  3. A 6-month observation period.

The primary objective is to assess the effect of 6 months of treatment with teriparatide 20 µg/day versus placebo on the proportion of men and postmenopausal women of at least 50 years of age with no revision surgery 12 months after internal fixation of a low-trauma femoral neck fracture.

All participants will receive supplements of calcium and vitamin D beginning at screening and continuing for 12 months.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

122

Fase

  • Fase 3

Contacten en locaties

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Studie Locaties

  • Australië
    • New South Wales
      • Penrith, New South Wales, Australië, 2751
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    • Victoria
      • Heidelberg, Victoria, Australië, 3081
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      • St Albans, Victoria, Australië, 3021
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    • Western Australia
      • Nedlands, Western Australia, Australië, 6009
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  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 2P9
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      • St. Catharines, Ontario, Canada, L2R 5J7
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    • Quebec
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  • Denemarken
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      • Hillerod, Denemarken, Dk-3400
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      • Kobenhavn, Denemarken, 2400
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      • Koege, Denemarken, 4600
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  • Estland
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  • Finland
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      • Turku, Finland, SF-20520
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  • Hongkong
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  • Indië
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      • Attavar, Mangalore, Indië, 575001
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      • Bangalore, Indië, 560 054
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      • Hyderabaad, Indië, 500033
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      • Nagpur, Indië, 444001
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      • Vadodara, Indië, 390018
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  • Israël
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      • Jerusalem, Israël, 91240
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  • Japan
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      • Chiba, Japan, 275-8580
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      • Fukuoka, Japan, 831-0016
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      • Fukushima, Japan, 961
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      • Gunma, Japan, 371-0014
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      • Hiroshima, Japan, 739-0696
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      • Ibaraki, Japan, 305-0854
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      • Japan, Japan, 399-8292
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      • Kagawa, Japan, 765-8507
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      • Nagano, Japan, 390-8510
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      • Niigata, Japan, 950-1197
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      • Ohita, Japan, 874-0011
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      • Osaka, Japan, 586-8521
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      • Saga, Japan, 840
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      • Shimane, Japan, 697-8511
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      • Shizuoka, Japan, 411-8611
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      • Toyama, Japan, 939-1395
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      • Toyko, Japan, 208-0011
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      • Yamaguchi, Japan, 754-0002
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      • Yamanashi, Japan, 400-8506
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  • Korea, republiek van
      • Seongnam-Si, Korea, republiek van, 463-707
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      • Seoul, Korea, republiek van, 135 720
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  • Letland
      • Riga, Letland, 1005
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  • Litouwen
      • Kaunas, Litouwen, 44320
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      • Klaipeda, Litouwen, 92228
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      • Vilnius, Litouwen, 04130
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  • Nieuw-Zeeland
      • Christchurch, Nieuw-Zeeland, 8022
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      • Takapuna, Nieuw-Zeeland, 0622
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      • Wellington South, Nieuw-Zeeland, 6021
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  • Noorwegen
      • Toensberg, Noorwegen, NO-3103
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  • Puerto Rico
      • San Juan, Puerto Rico, 00936-5067
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  • Spanje
      • Alcira, Spanje, 46600
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      • Barcelona, Spanje, 08025
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      • Girona, Spanje, 17007
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      • Guadalajara, Spanje, 19002
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      • Marbella, Spanje, 29600
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      • Pozuelo De Alarcon, Spanje, 28223
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  • Taiwan
      • Jhonghe City, Taiwan, 235
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      • Kaohsiung, Taiwan, 824
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      • Taichung, Taiwan, 40705
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      • Taichung City, Taiwan, 40201
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      • Taipei, Taiwan, 220
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  • Verenigde Staten
    • Arizona
      • Phoenix, Arizona, Verenigde Staten, 85027
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      • Tucson, Arizona, Verenigde Staten, 85712
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    • California
      • La Mesa, California, Verenigde Staten, 91942
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      • Laguna Hills, California, Verenigde Staten, 92653
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      • Lancaster, California, Verenigde Staten, 93534
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      • Pasadena, California, Verenigde Staten, 91101
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    • Connecticut
      • Danbury, Connecticut, Verenigde Staten, 06810
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    • Florida
      • Boca Raton, Florida, Verenigde Staten, 33486
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      • Bradenton, Florida, Verenigde Staten, 34209
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      • Miami, Florida, Verenigde Staten, 33136
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      • Orlando, Florida, Verenigde Staten, 32804
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    • Idaho
      • Idaho Falls, Idaho, Verenigde Staten, 83404
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    • Michigan
      • Royal Oak, Michigan, Verenigde Staten, 48073
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    • Missouri
      • Columbia, Missouri, Verenigde Staten, 65212
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      • Springfield, Missouri, Verenigde Staten, 65804
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    • Montana
      • Billings, Montana, Verenigde Staten, 59101
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      • Great Falls, Montana, Verenigde Staten, 59405
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    • Nebraska
      • Omaha, Nebraska, Verenigde Staten, 68131
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    • North Carolina
      • Asheville, North Carolina, Verenigde Staten, 28801
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    • North Dakota
      • Fargo, North Dakota, Verenigde Staten, 58103
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    • Pennsylvania
      • York, Pennsylvania, Verenigde Staten, 17405
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    • Texas
      • Houston, Texas, Verenigde Staten, 77043
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Antonio, Texas, Verenigde Staten, 78229
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Utah
      • Salt Lake City, Utah, Verenigde Staten, 84108
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
  • Zweden
      • Malmo, Zweden, 205 02
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Mölndal, Zweden, 43180
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Stockholm, Zweden, SE-118 83
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Community dwelling men and postmenopausal women who were ambulatory before sustaining a low-trauma, unilateral femoral neck fracture (displaced or nondisplaced)
  • Other than femoral neck fracture, be free of incapacitating conditions and have a life expectancy of at least 2 years
  • Have received or are eligible for treatment with internal fixation (sliding hip screw or multiple cancellous screws) for the femoral neck fracture (the surgical procedure itself is not performed as part of this study)
  • Have given written informed consent (participant or proxy) after being informed of the risks, medications, and study procedures

Exclusion Criteria:

  • Increased baseline risk of osteosarcoma
  • History of unresolved skeletal diseases affecting bone metabolism other than primary osteoporosis
  • Abnormally elevated serum calcium at screening
  • Abnormally elevated serum intact parathyroid hormone (PTH) (1-84) at screening
  • Severe vitamin D deficiency at screening
  • Active liver disease or jaundice
  • Significantly impaired renal function
  • Abnormal thyroid function not corrected by therapy
  • History of malignant neoplasm in the 5 years prior to screening
  • History of bone marrow or solid organ transplantation
  • History of symptomatic nephrolithiasis or urolithiasis in the 1 year prior to screening
  • Previous treatment with the following bone active drugs is allowed but must be discontinued at screening: oral bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, estrogen (oral, transdermal, or injectable), progestin, estrogen analog, estrogen agonist, estrogen antagonist or tibolone, and active vitamin D3 analogs. Androgen or other anabolic steroid use must be discontinued, except for use of physiologic replacement testosterone
  • Previous treatment with the following bone active drugs is exclusionary, if the stated treatment durations have been met: strontium ranelate for any duration, intravenous bisphosphonates in the 12 months preceding screening, and/or denosumab in the 6 months preceding screening
  • Prior treatment with PTH, teriparatide, or other PTH analogs, or prior participation in any other clinical trial studying PTH, teriparatide, or other PTH analogs
  • Local or systemic treatment with bone morphogenic proteins or any other growth factor
  • Previous fracture(s) or bone surgery in the currently fractured hip
  • Soft-tissue infection at the operation site
  • Treatment with bone grafting or osteotomies
  • Treatment with augmentation using any type of degradable cement, hydroxyapatite-coated implants, or with noninvasive interventions
  • Associated major injuries of a lower extremity including fractures of the foot, ankle, tibia, fibula, knee, femur, femoral head or pelvis; dislocations of the ankle, knee or hip

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo
Eenmaal daags toegediend via subcutane (SC) injectie gedurende 6 maanden
Geneesmiddel: Placebo
Toegediend door middel van SC-injectie
Voedingssupplement: Calcium suppletie
Oraal toegediend
Voedingssupplement: Suppletie van vitamine D
Oraal toegediend
Experimenteel: Teriparatide
20 microgram (µg) eenmaal daags toegediend via subcutane injectie gedurende 6 maanden
Voedingssupplement: Calcium suppletie
Oraal toegediend
Voedingssupplement: Suppletie van vitamine D
Oraal toegediend
Geneesmiddel: Teriparatide
Toegediend door middel van SC-injectie
Andere namen:
  • Forteo
  • LY333334
  • Forsteo

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage deelnemers zonder revisieoperatie 12 maanden na interne fixatie van een laaggetraumatiseerde femurhalsfractuur
Tijdsspanne: 12 maanden
Revisiechirurgie (heroperatie) werd gedefinieerd als elke aanvullende chirurgische ingreep die werd uitgevoerd of aanbevolen op de plaats van de indexprocedure, behalve degene die gepland waren op het moment van de indexprocedure.
12 maanden

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Percentage of Participants With Radiographic Evidence of Healing
Tijdsspanne: Randomization up to 12 months

The signs of femoral neck fracture healing included disappearance of the fracture line on radiographs. If a participant had radiographic evidence of healing at the 12-month visit, that participant was considered to have radiographic evidence of healing.

Percentage was calculated as: (number of participants with radiographic evidence of healing / total number of participants analyzed) * 100.
Randomization up to 12 months
Percentage of Participants With Pain Control During Ambulation
Tijdsspanne: Up to 12 months
The worst pain numeric rating scale (NRS) was used to assess the impact of pain on a participant's life. NRS Item 3 assessed the worst musculoskeletal pain severity during the walking test. Pain was measured by an 11-point Likert scale. The following cut-points were used to categorize the NRS responses: 0 = no pain, 1 to 4 = mild pain, 5 to 6 = moderate pain, and 7 to 10 = severe pain. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain with ambulation and no worsening of NRS scores >2 from baseline. Percentage was calculated as: (Number of participants with pain control during ambulation / total number of participants) * 100.
Up to 12 months
Percentage of Participants Without Severe Fracture-Site Pain During 24 Hours Prior to Visit
Tijdsspanne: Up to 12 months
The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain in the 24 hours preceding a visit. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 in the 24 hours preceding a visit and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during 24 hours preceding a visit / total number of participants) * 100.
Up to 12 months
Percentage of Participants Without Severe Fracture-Site Pain During Weight Bearing
Tijdsspanne: Up to 12 months
The worst pain NRS was used to assess the impact of pain on a participant's life. Fracture-site pain severity was assessed for pain on weight bearing. Pain was measured by an 11-point Likert scale. Participants with an NRS score of <7 during weight bearing and no worsening of NRS >2 from baseline were categorized as having no severe fracture-site pain. Percentage was calculated as: (number of participants with pain control during weight bearing / total number of participants) * 100.
Up to 12 months
Percentage of Participants With Functional Evidence of Healing
Tijdsspanne: 12 Months

Functional healing was defined as ability to walk with a gait speed ≥ 0.05 meters/second (m/s) with a change from baseline ≥ -0.1 m/s. The walking test involved having the participant walk a distance of 7 meters (m) at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s.

Percentage was calculated as: (number of participants with functional evidence of healing / total number of participants analyzed) * 100.
12 Months
Percentage of Participants Able to Ambulate
Tijdsspanne: Up to 12 months
Ability to ambulate was defined as ambulatory with convalescent aid or without convalescent aid. Percentage was calculated as: (number of participants able to ambulate / number of total participants analyzed) * 100.
Up to 12 months
Percentage of Participants Who Regain Their Prefracture Ambulatory Status
Tijdsspanne: Up to 12 months
Prefracture ambulatory status was defined as either ambulatory with or without a walking aid. A participant was considered to have regained their prefracture ambulatory status if the participant's postsurgery ambulatory status was returned to or was improved from their pre-surgery ambulatory status. Percentage was calculated as = (number of participants who regained their ambulatory status / total number analyzed) * 100.
Up to 12 months
Mean Change From Baseline to 6 Months in Worst Fracture-Site Pain
Tijdsspanne: Baseline, 6 Months
The worst pain NRS was used to assess the impact of pain on a participant's life. Participants with an NRS score of <7 were categorized as having no severe fracture-site pain. Least Squares (LS) means was calculated using analysis of covariance (ANCOVA) and adjusted for baseline, treatment group, region, fracture type, and fixation type.
Baseline, 6 Months
Mean Change From Baseline to 6 Months in Gait Speed
Tijdsspanne: Baseline, up to 6 Months
The walking test involved having the participant walk a distance of 7 m at a self-selected, comfortable pace. A 4-m portion of the test was timed to determine the participant's gait speed in m/s. LS means was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, and fixation type.
Baseline, up to 6 Months
Time to Revision Surgery
Tijdsspanne: Baseline to revision surgery (up to 14.14 Months)
Time to revision surgery was defined as the time from initial hip fracture surgery to revision surgery, or recommendation for revision surgery if recommended but not performed. Time to revision surgery was censored at the date of the last contact.
Baseline to revision surgery (up to 14.14 Months)
Mean Change From Baseline to 6 Months on Short Form-12 (SF-12) Physical (PCS) and Mental Component Summary (MCS) Scores
Tijdsspanne: Baseline, up to 6 Months
SF-12 is a self-reported questionnaire covering a mental component score (MCS) and a physical component score (PCS), each scoring from a 0 to 100 (worst to best) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Baseline, up to 6 Months
Mean Change From Baseline to 6 Months on Western Ontario McMaster Osteoarthritis Index (WOMAC)
Tijdsspanne: Baseline, up to 6 Months
WOMAC is: a self-reported questionnaire that consisted of 24 questions covering 3 health domains: Pain (5 items: during walking, using stairs, in bed, sitting or lying, and standing), Stiffness (2 items: after first waking and later in the day), and Physical Function. Each domain was scored by summing the individual items and transforming the scores into a 0 to 100 (best to worst) scale. LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, region, fracture type, fixation type, visit, and visit-by-treatment interaction.
Baseline, up to 6 Months
Mean Change From Baseline to 6 Months on European Quality of Life Questionnaire (EQ-5D) Health State Score
Tijdsspanne: Baseline, up to 6 Months
The EQ-5D is a 5-item, self-reported, generic, multidimensional, health-related, quality-of-life instrument with 5 items. Overall health state score was also self-reported using a visual analogue scale (VAS) marked on a scale scored from 0 (worse imaginable health state) to 100 (best imaginable health state). LS mean was calculated using ANCOVA and adjusted for baseline, treatment group, and region.
Baseline, up to 6 Months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Eli Lilly and Company

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2012

Primaire voltooiing (Werkelijk)

1 december 2013

Studie voltooiing (Werkelijk)

1 december 2013

Studieregistratiedata

Eerst ingediend

14 november 2011

Eerst ingediend dat voldeed aan de QC-criteria

14 november 2011

Eerst geplaatst (Schatting)

17 november 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

16 april 2015

Laatste update ingediend die voldeed aan QC-criteria

10 april 2015

Laatst geverifieerd

1 april 2015

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 13467
  • B3D-MC-GHDN (Andere identificatie: Eli Lilly and Company)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Dijbeen Nek Fractuur

Klinische onderzoeken op Placebo

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Medische omstandigheden

Geneesmiddelinterventies

CROs by country

CROs in Ghana

Voorwaarden

Zeldzame ziekten

Geneesmiddelinterventies

Voedingssupplementen

Sponsor / medewerkers

Locaties

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