Olpadronate intra venous in chronic low back pai

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Informed consent must be given before any assessment is performed
- Men or women of 21 years of age or older
- Axial spine back pain persisting for at least three months
- MRI evidence of disc degeneration and/or any imaging evidence of vertebral changes consistent with the diagnosis of degenerative disc disease, spondylotic disease of the lumbar spine or an old vertebral fracture
- A Baseline Average Pain Intensity of 4 or higher. [subjects will rate their daily average pain intensity, on a scale from 0-10, and enter their response into an electronic diary. Baseline Average Pain Intensity (BSL-API) is calculated from daily average pain intensity scores obtained from electronic diary entries during the 7 days prior to the first infusion at BSL]. Subjects have to fill in the electronic diary correctly 4 days out of 7 as a minimum.
- Subjects who are – in the opinion of the investigator – able to understand all study procedures and willing to comply with all study requirements.

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 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- A history of prior back surgery
- A documented clinical vertebral fracture within 6 months of study entry
- A history of cancer in the past 5 years, except for non-melanoma skin cancer that has been treated with no evidence of recurrence in the past 3 months
- carcinoma in situ of the cervix
- colon polyps with non-invasive malignancy that have been removed
- A history of hypocalcaemia
- 25-hydroxy Vit D levels < 30 nmol/L (12.5 ng/ml).
- An estimated glomerular filtration rate (GFR) less than 35 ml/min
- Current clinically significant cardiac, haematological, hepatic, endocrine (e.g. primary hyperparathyroidism, uncontrolled hyper- or hypothyroidism), psychiatric (severe depression), or neurological disease
- Diagnosed metabolic bone disease such as Paget’s disease and Osteogenesis Imperfecta. However, osteoporosis is NOT an exclusion criterion.
- Any prior use of intravenous bisphosphonates or oral bisphosphonates in the last 3 years. Any prior use of any other antiresorptives is NOT an exclusion criterion.
- A known allergy to bisphosphonates
- Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they are using a highly effective method of birth control (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices (IUDs)). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) are not acceptable
- A present history of alcohol abuse
- BDI score of 29 or more
- Subjects have had a tooth extraction or any invasive dental procedure within three months prior to study enrolment; have poor oral hygiene or inadequate dental care in the opinion of the investigator
- Subjects who have received systemic glucocorticoid therapy within 3 months of enrolment in the study

No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible subjects.