The effects of growth hormone, strontium ranelate and phosphate on PTH circadian rhythm, PTH target organ sensitivity, bone turnover markers, phospho-calcium metabolism and bone mineral density. A prospective, open labelled study. - Effects of anabolic therapies on PTH circadian rhythm & sensitivity

Phase 1

• Conditions: Osteoporosis and Reduced Bone mineral density (T scores< -1.0 on DEXA scan), Adult growth hormone deficiency ( GH levels,9mU/l on Insulin stress test) with reduced BMD (T scores< -1.0 on DEXA scan)

• Registration Number: EUCTR2005-004316-73-GB
• Lead Sponsor: Royal Liverpool University hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-12
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1.Postmenopausal women(no spontaneous menses for 2years or more) >55 years with reduced BMD (T score < -1.0 on DEXA scan)
2.Men with reduced BMD (T score <-1.0 on DEXA)
3.Adult Growth Hormone Deficiency (defined as a peak GH response of less than 9mU/litre (3 microg/litre) to hypoglycaemia
(blood glucose <2.2mmol/litre) induced during an insulin stress test).
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Abnormal PTH, calcium, phosphate, vitamin D (<10 ng/ml), testosterone, thyroid function (except stable thyroxine replacement) on baseline testing
•Diabetes
•Unstable angina
•NYHA heart failure grades III and IV
•Liver disease (liver function tests >3 times upper limit of normal)
•Renal disease (Creatinine > 150µmol/l)
•Patients with nephrocalcinosis (renal stone )
•Malignant carcinomas, tumour activity, excluding basal cell carcinoma of skin
•Previous vertebral or hip fracture
•Ongoing treatment with corticosteroids, bisphosphonates, diuretics, calcium and vitamin D (pharmacological doses)
•Women on HRT
•Previous venous thromboembolism
•Patients with uncontrolled or accelerated hypertension
•Patients with Phenylketonuria
•Patients who refuse to participate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified