A Phase 2 Study for Transdermal Application of Teriparatide

• Conditions: Treatment of osteoporosis in postmenopausal women; MedDRA version: 14.0Level: PTClassification code 10031285Term: Osteoporosis postmenopausalSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2009-011883-12-EE
• Lead Sponsor: Elli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 233

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria:
[1]Ambulatory, postmenopausal women aged 45 to 85 years inclusive at the time of entry into the trial, whose last menstrual period occurred at least 2 years prior to entry into the trial. Women below the age of 55 years in whom a bilateral oophorectomy cannot clearly be documented must have their postmenopausal status confirmed by a serum follicle stimulating hormone (FSH) level of >30 IU/L and serum estradiol level of <20 pg/ml or <73 pmol/L.
[2]Centrally confirmed lumbar spine or femoral neck BMD T-score of =2.5 as measured by DXA. Absolute values should be used for assessing BMD and are as follows:
Skeletal Site BMD Absolute Value (g/cm2)
(T-score <-2.5)
Hologic Lunar
Lumbar Spine (L1-L4)<_0.772<-0.872
Femoral Neck <_0.558<_0.691

[3]Three of 4 vertebrae, L1 through L4, must be evaluable for BMD scoring, as measured by DXA.
[4]Free of severe or chronically disabling conditions other than osteoporosis (for example, uncontrolled diabetes or diabetes with significant renal, vascular, neurologic, or ophthalmic complications).
[5]Able to use a pen-type injection delivery system satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver who can meet daily with the patient and is willing to be trained on and use the pen-injector on a daily basis.
[6]Able to use the ViaDerm Teriparatide System satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver who can meet daily with the patient and is willing to be trained on and use the ViaDerm Teriparatide System on a daily basis.
[7]Without language barrier, cooperative, expected to return for all follow-up procedures, and have given informed consent after being informed of the risks, medications, and procedures to be used in the study.
[8]Able to be reached by telephone for follow-up contact between visits.

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 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 168

Exclusion Criteria

[1] Abnormal laboratory values for albumin and alkaline phosphatase (normal range as defined by the central laboratory), except for clinically insignificant values as determined by the investigator in conjunction with the Lilly physician.
[2]Laboratory values outside the ranges for the following:
Serum calcium 8.3 -10.6 mg/dL (conventional units)
2.07 - 2.64 mmol/L (SI units)
iPTH(1 84)b 11-72 pg/mL (conventional units)
1.2-7.6 pmol/L (SI units)
25 hydroxyvitamin D levels 20 to 61 ng/mL (conventional units)
50-153 pmol/mL (SI units)
aRanges specified for adults =18 years of age.
bRange using the Centaur Method.

[3]24-hour urine calcium higher than 300 mg/day.
[4]Abnormal thyroid function not corrected by therapy.
[5]Significantly impaired renal function. This is defined as:
-serum creatinine >2.0 mg/dL or 177 micromol/L; or
-measured or calculated creatinine clearance that, in the opinion of the investigator, indicates significant renal impairment.
[6]Significantly impaired hepatic function, defined as:
•single transaminase (alanine transaminase [ALT], aspartate transaminase [AST], or gamma-glutamyl transpeptidase [GGT]) greater than 3 times the upper limit of normal (ULN); or
total bilirubin greater than 2.0 mg/dL (34 micromol/L).
[7]History of diseases other than postmenopausal osteoporosis that affect bone metabolism, such as Paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, and intestinal malabsorption.
[8]History of malignant neoplasms in the 5 years prior to randomization,
[9]History of nephrolithiasis or urolithiasis in the 2 years prior to randomization.
[10]Use of a pacemaker.
[11]Patients prone to bleeding with coagulopathies, such as hemophilia or thrombocytopenia.
[12]History of excessive consumption of alcohol or abuse of drugs in the 1 year prior to randomization, in the opinion of the investigator.
31 Prior participation in any other clinical trial studying or prior treatment with denosumab or strontium ranelate

Study & Design

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