A Single Centre, Single Arm, Exploratory, Open Label Study to Determine the Early Bone Formation and Bone Resorption Biomarker Response Profile of a Potent BoneAnabolic Treatment (PTH-1-34) with Daily Subcutaneous Administration, in Osteoporotic and Osteopenic Postmenopausal Women - CPJMR0062101

Conditions: Osteopenic and Osteoporotic postmenopausal women
MedDRA version: 8.1Level: LLTClassification code 10031282Term: Osteoporosis

Registration Number: EUCTR2006-004110-40-GB

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 15

Inclusion Criteria

1) Female subjects more than 55 years of age inclusive.
2) Post menopausal status according to the following guidelines:
-Cessation of menses for >5 years Or documented bilateral oophorectomy at least 1 year previously
-Cessation of menses for <25 years
-In women >55 and < 60 years of age, FSH level >30 IU/l (confirmed prior to dosing)
3) Diagnosis of osteoporosis or osteopenia with a Bone Mineral Density T score = -1 at the Lumbar spine or total hip.
4) Normocalcemia Serum Calcium =2.0 mmol/l and =2.5mmol/l.
5) Vitamin D 25-(OH) Serum level of = 15ng/ml.
6)Otherwise in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, standard laboratory tests and urinalysis at screening, and the opinion of the investigator.
7) Screening BMI must be >18.5 and =28 and subjects must weigh at least 50 kg to participate in this study.
8) At screening and baseline vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed after the subject has rested for at least 3 mins and again when required after 3 mins in the standing position.
9) Able to communicate well with the investigator to understand and comply with the requirements of the study. Understand and sign the written informed consent.
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

1) Subjects who are using or have used in the past 12 months any of the following
medications: strontium ranelate, bisphosphonate (no bisphosphonate use permitted in last 24 months), PTH, Oestrogens, HRT including SERMs, Calcitonin, aluminium supplements.
2) Subjects with a history of chronic use of systemic corticosteroids (oral or i.v.) within the last year where the total dose exceeds 750 mg of oral prednisone or equivalent: NOTE: Use of corticosteroids in forms such as topical creams, nasal or inhaled formulations or those injected locally (intra-articular) more than one month prior to screening are NOT exclusionary.
3) Subjects who are using or have used in the past 3 months any of the following
medications: Statins, Thiazide Diuretics, ß-blockers, diphenylhydantoin or other anticonvulsants and heparin.
4) Subjects with cancer of history of malignancy of any organ system, treated or untreated, at anytime, whether or not there is evidence of local recurrence or metastases. Some exceptions described in the protocol will apply.
5) Subjects with any of the following:
- a +ve HBsAg or Hep C test result.
- history og immunodeficiency diseases, inclu a +ve HIV test result.
- clinically significant abnornmal liver function tests such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin.
- clinically significant abnormal creatinine or BUN values or abnormal urinary constituents.
- evidence of urinary obstruction or difficultly in voiding at screening.
6) Patients with 25- (OH) Vit D levels less than 15 ng/mL prior to randomisation.
7) subjects with metabolic bone disease, such as paget's disease, crushing syndrome, acromegaly, osteogenesis imperfecta, or serious illness affecting normal bone homeostasis (by history and physical)
8) Subjects exhibing or with a history of any of the following signs and symptoms,
- high caffeine intake, vertebral tenderness, surgical scar on neck suggestive of prior thyroid surgery, Rachitic rosary or any bone deformities suggestive or prior rickets, Cafe au lait spots, neuromuscualar irritability.
9) Subjects with measured abnormal safety laboratory values.
10) Subjects with anorexia nervosa, suspected bulemia, or obvious malnutrition.
11) History of drug or alcohol abuse within 12 months prior to dosing.
12) Smokers - more than 20 cigarettes per day used.
13) Subjects who have started Vit D or calcium supplements less than 1 month prior to screening.
14) Participation in any clinical investigation within 4 weeks prior to dosing or longer if required.
15) Blood donors or loss of 400ml or more of blood within 8weeks prior to screening.
16) Significant illness within 2 weeks prior to dosing.
17) History of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
18) History of clinically significant drug allergy or hostory of atopic allergy (asthma, urticaria, eczematous dermatitis). A known hypersensitivity to the study drug or drugs similar to the study drug.