Does postoperative treatment with parathyroidea hormone Forteo® improve the disability in elderly patients undergoing spinal stabilization fusion surgery compared with patients treated with placebo. If that is the case, is there a correlation between improvement of disability and solid osseous healing?

Postoperative treatment with parathyroidea hormone Forteo® in patients undergoing posterolateral spinal fusion surgery. A prospektive and a randomized double-blinded, placebo-controlled study - PTH-U-DESE-STUDY

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006152-36-DK

Enrollment

100

Registered

2012-05-10

Start date

2012-05-10

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal stenosis MedDRA version: 14.1 Level: LLT Classification code 10041597 Term: Spinal stenosis of lumbar region System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Trade Name: Forteo Product Name: Forsteo Product Code: 0002-8971 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: teriparatide [rDNA origin] contains recombinant huma

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Spinal stenosis verified by MRI Age 60 or above No diagnosed dementia (MMSE 24 of 30 correct answers) Considerable reduction in walking distance which has not improved during conservative treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85

Exclusion criteria

Exclusion criteria: Contraindication for PTH treatment Major deformity Mental illness Spinal cord compression due to infection or malignant disease Resent spinal fracture hypercalcemia Reduced kidney function Metabolic bone disease, including hypophosphatemia Untreated anti coagulant treatment Previous radiation therapy Haematological disorders Previously fusion spinal surgery Age under 60

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim of this study is to examine the effect on clinical outcome of postoperative treatment with Forteo® by evaluating self reported disability,(ADL functions-data) in elderly patients undergoing spinal stabilization surgery compared with placebotreatment. ;Secondary Objective: The secondary objectives are to define -if the patients walking distance is improved - if the level of pain is reduced. And if a better fusionrate on CT and DEXA -scan correlate with the functional outcome of treatment with Forteo®, i.e. if the walking distance is improved or the level of pain is reduced. ;Primary end point(s): The primary endpoint is to examine the effect and clinical outcome of postoperative treatment with Forteo in elderly patients undergoing spinal stabilization surgery compared with placebotreatment using selfreported questionnaires evaluating disability (DPQ, SF36, ODI, and EQ-5D) præ and postoperative. ;Timepoint(s) of evaluation of this end point: By measuring the patients' state of health and disability ADL functions-data (DPQ) before at inclusion (baseline) and after 3,6,12 and 24 months.	—

Measure

Time frame

Main Objective: The primary aim of this study is to examine the effect on clinical outcome of postoperative treatment with Forteo® by evaluating self reported disability,(ADL functions-data) in elderly patients undergoing spinal stabilization surgery compared with placebotreatment. ;Secondary Objective: The secondary objectives are to define -if the patients walking distance is improved - if the level of pain is reduced. And if a better fusionrate on CT and DEXA -scan correlate with the functional outcome of treatment with Forteo®, i.e. if the walking distance is improved or the level of pain is reduced. ;Primary end point(s): The primary endpoint is to examine the effect and clinical outcome of postoperative treatment with Forteo in elderly patients undergoing spinal stabilization surgery compared with placebotreatment using selfreported questionnaires evaluating disability (DPQ, SF36, ODI, and EQ-5D) præ and postoperative. ;Timepoint(s) of evaluation of this end point: By measuring the patients' state of health and disability ADL functions-data (DPQ) before at inclusion (baseline) and after 3,6,12 and 24 months.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints are testing the patients walking distance, level of pain (especially legpain) and use of analgesics præ and postoperative at (baseline) and after 3,6,12 and 24 months after. Also DEXA- scans (and blood samples control for monitoring the patients calcium level) controls at OUH, Odense, where the patients' fusionrate and fusion mass are evaluated at (baseline) and after 10 days,1,3,6,12 month. Futher “Thin slice CT” controls are evaluated postoperative at 6 and 12 months to evaluate the fusionrate. ;Timepoint(s) of evaluation of this end point: Baseline (10 days and 1 month), 3,6,12 and 24 months.	—

Measure

Time frame

Secondary end point(s): Secondary endpoints are testing the patients walking distance, level of pain (especially legpain) and use of analgesics præ and postoperative at (baseline) and after 3,6,12 and 24 months after. Also DEXA- scans (and blood samples control for monitoring the patients calcium level) controls at OUH, Odense, where the patients' fusionrate and fusion mass are evaluated at (baseline) and after 10 days,1,3,6,12 month. Futher “Thin slice CT” controls are evaluated postoperative at 6 and 12 months to evaluate the fusionrate. ;Timepoint(s) of evaluation of this end point: Baseline (10 days and 1 month), 3,6,12 and 24 months.

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Countries

Denmark

Contacts

Public ContactKaren Højmark

Rygkirurgisk forskningsenhed, SLB

004563484198

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026