A multicentre randomized, double blind, controlled trial for the effect of PTH(1-34) for the reduction of low back pain in patients with osteoporosis and disc degeneration

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800018620

Enrollment

Unknown

Registered

2018-09-30

Start date

2018-12-01

Completion date

Unknown

Last updated

2018-10-01

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

Conditions

disc degeneration, low back pain

Interventions

Group 1:PTH(1-34)

Group 2:Placebo

Eligibility

Sex/Gender

All

Age

45 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 45~65 years male and female; 2. With a main complaint of low back pain> 6 months; 3. Present with degeneration of lumber intervertebral disc disease (Pfirrmann Grade 3-5); 4. T-Score between -2.5 to -1, Oswestry Disability Index> 30; 5. Serium Ca2+, P, PTH, 1,25-dihydroxyvitamin D3 [1,25-(OH),D3],and?ALP were normal; 6. Willing and guarantee to cooperate in accordance with program requirements.

Exclusion criteria

Exclusion criteria: 1. Severe osteoporosis(T-Score 3mm); 5. Any fracture of the lamina; 6. Scoliosis > 11 degree; 7. Lumbar instability (Cobb angular change >13 degree); 8. Small joint disorder syndrome; 9. Thoracic/lumbar fusion; 10. Spinal fracture; 11. arachnoiditis; 12. Metabolic bone disease; 13. Osteosarcoma or other cancer; 14. Pregnant or lactating; 15. Mental disorders; 16. Involved in another medical research; 17. Severe heart, lung, liver and kidney disease; 18. Immune system diseases such as chronic lymphocytic leukemia lymphoma of AIDS lupus erythematosus or bone Paget disease, unknown cause of alkaline phosphatase elevation, open epiphysis, bone metastasis or bone malignant tumor patients; 19. With other uncontrolled diseases; 20. Suffering from any diseases or factors that the researcher think it should exclude; 21. nerve root or spinal cord pinching; 22. currently pregnancy, breastfeeding or intend to become pregnant within the study period; 23. PTH was used before the study.

Design outcomes

Primary

Measure	Time frame
MRI;	—

Countries

China

Contacts

Public ContactXuenong Zhou

The First Affiliated Hospital of Sun Yat-sen university

zxnong@hotmail.com+86 13724897260

Outcome results

None listed

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