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?

• Register: EUCTR
• Last refreshed on: 30 November 2020
• Main ID: EUCTR2011-006152-36-DK
• Date of registration: 10/05/2012
• Prospective Registration: Yes
• Primary sponsor: Middelfart Rygsektor
• Public title: 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?
• Scientific title: 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
• Date of first enrolment: 10/05/2012
• Target sample size: 100
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-006152-36
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Denmark

Contacts

• Name: Karen Højmark
• Affiliation: Rygkirurgisk forskningsenhed, SLB

• Name: Karen Højmark
• Affiliation: Rygkirurgisk forskningsenhed, SLB

Key inclusion & exclusion 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:
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




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

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 human parathyroid hormone (1-34)
CAS Number: 52232-67-4
Other descriptive name: rhPTH (1-34)
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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.

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.

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.

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.

Secondary Outcome(s)

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.

Secondary ID(s)

1774

Source(s) of Monetary Support

Eli Lilly

Ethics review

Status: Approved
Approval date: 23/01/2012
Contact: