18F-fluoride PET for Early Non-invasive Assessment of Cortical Bone Formation - Non-invasive Assessment of Cortical Bone Formation - Version 1

King’s College London0 sites30 target enrollmentNovember 9, 2009

Overview

No summary available.

Registry

who.int

Start Date

November 9, 2009

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•Subjects will be eligible for entry into the study if they meet all the following inclusion criterion:
•Ambulatory postmenopausal\* women.
•Aged 50 to 85 years inclusive.
•Free of severe or chronically disabling condition.
•Without language barrier, cooperative, expected to return for all follow\-up visits and who give written informed consent before entering the study.
•Lumbar spine, femoral neck and/or total hip BMD between 1 and 2\.5 standard deviations below the average bone mineral density for young healthy women (i.e. T\-score \=\-1 to \> \-2\.5\) as determined from the manufacturer’s database.
•Normal or clinically insignificant abnormal laboratory values.
•Normocalcemia Serum Calcium \=2\.15 mmol/l and \=2\.55 mmol/l.
•Vitamin D 25\-(OH) Serum level of \=15 ng/ml (37\.4 nmol/L)
•Otherwise in good health as determined by past medical history, physical examination, vital signs, standard laboratory tests and urinalysis at screening and the opinion of the investigator.

•Subjects will be excluded from the study if they meet any of the following criteria:
•Current or recent (within 1 year of enrolment) metabolic bone disorders such as Paget’s disease of bone, Cushing’s Syndrome, acromegaly, osteogenesis imperfecta, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis and/or bone loss, or serious illness affecting normal bone homeostasis.
•Current or recent (within 1 year of enrolment) disease which affects bone metabolism, such as hypoparathyroidism, hyperparathyroidism, or hyperthyroidism.
•Subjects with a history of hypothyroidism not on stable replacement therapy with levothyroxine (defined as no change of dose for at least 6\-months prior to enrolment)
•Subjects with skeletal malignancies or bone metastases
•Recent (within 6\-months of enrolment) fracture at any skeletal site.
•Significant osteoarthritis of the lumbar spine and/or hip(s) precluding a satisfactory DXA or 18F\-fluoride PET scan.
•History of carcinoma in the previous 5 years or currently suspected carcinoma, with the exception of excised superficial lesions such as basal cell carcinoma and squamous cell carcinoma of the skin.
•Current or recent (within 1 year of enrolment) inflammatory bowel disease or malabsorption syndrome.
•Pre\-existing hypercalcaemia