Conditions

Osteoporosis

Keywords

Age Related OsteoporosisSenile Osteoporosis

Outcome Measures

Primary Outcomes (1)

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 12 Months
Bone mineral density (BMD) of the lumbar spine was assessed by dual energy X-ray absorptiometry (DXA). BMD values are corrected data and have been standardized across the machine types (Hologic and Lunar). Analyses were performed using ANCOVA model and least square (LS) means were adjusted for baseline BMD values as a covariate and pooled site and treatment as fixed effects.
Baseline, 12 Months

Secondary Outcomes (15)

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at 6 Months
Baseline, 6 Months
Time Course Change of BMD Response at the Lumbar Spine
Baseline to 6 Months and 12 Months
Percent Change From Baseline in Procollagen Type 1 N-Terminal Propeptide (P1NP)
Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change From Baseline of C-Terminal Telopeptide (CTX)
Baseline, 1 Month, 3 Months, 6 Months, 12 Months
Percent Change From Baseline in Serum Procollagen Type 1 C-Propeptide (P1CP) at 1 Month
Baseline, 1 Month
+10 more secondary outcomes

Study Arms (4)

20 mcg Subcutaneous Teriparatide

ACTIVE COMPARATOR

Received 20 micrograms (mcg) subcutaneously once daily in an unblinded manner.

Drug: Subcutaneous Teriparatide

30 mcg Transdermal Teriparatide

EXPERIMENTAL

Received 30 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.

Drug: Transdermal Teriparatide

50 mcg Transdermal Teriparatide

EXPERIMENTAL

Received 50 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.

Drug: Transdermal Teriparatide

80 mcg Transdermal Teriparatide

EXPERIMENTAL

Received 80 micrograms (mcg) teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.

Drug: Transdermal Teriparatide

Interventions

Subcutaneous TeriparatideDRUG

Administered subcutaneously once daily for 12 months

Also known as: recombinant human parathyroid hormone (rhPTH) (1-34), recombinant human teriparatide, Forteo, Forsteo, LY333334

20 mcg Subcutaneous Teriparatide

Transdermal TeriparatideDRUG

Administered transdermally, applied once daily for 6 hours over 12 months

Also known as: synthetic human parathyroid hormone (shPTH) (1-34), synthetic human teriparatide

30 mcg Transdermal Teriparatide50 mcg Transdermal Teriparatide80 mcg Transdermal Teriparatide

Eligibility Criteria

Age55 Years - 80 Years

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ambulatory, postmenopausal women.
Centrally confirmed lumbar spine or femoral neck bone mineral density (BMD) T-score of less than or equal to -2.5.
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.
Able to use the pen-type injection delivery system and the ViaDerm Teriparatide System satisfactorily in the opinion of the investigator, or with the help of a family member or caregiver.
Able to be reached by telephone for follow-up contact between visits

You may not qualify if:

Abnormal laboratory values for albumin and alkaline phosphatase.
Laboratory values outside the ranges defined in the protocol for the following: Serum calcium, intact parathyroid hormone (iPTH), 25 hydroxyvitamin D, and 24-hour urine calcium
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.
History of malignant neoplasms in the 5 years prior to randomization, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. Patients with carcinoma in situ of the uterine cervix treated definitively more than 1 year prior to entry into the study may be randomized.
Use of a pacemaker.
Known chronic dermatological disorder, such as contact dermatitis
History of allergy or sensitivity to tapes or adhesives
Patients prone to bleeding with coagulopathies, such as hemophilia or thrombocytopenia.
Patients who have an increased baseline risk of osteosarcoma, Paget's disease of the bone, or unexplained elevations of alkaline phosphatase; or prior external beam, implant radiation therapy involving the skeleton, or previous primary skeletal malignancy.
Major fracture within the past year in the femur, tibia, humerus, or radius (with or without ulna).
Treatment with:
calcitonins in the 2 months prior to randomization.
oral, transdermal/patch, or injectable estrogens, progestins, estrogen analogs, estrogen agonists, estrogen antagonists, selective estrogen receptor modulators, or tibolone in the 3 months prior to randomization; treatment with intravaginal estrogens in doses higher than 0.3 mg of conjugated equine estrogen, or the equivalent, for more than 3 doses per week in the 3 months prior to randomization.
androgens or other anabolic steroids in the 6 months prior to randomization.
fluorides in the 2 years prior to randomization. (Previous or current use of fluoridated water or topical dental fluoride treatments are permitted.)
+7 more criteria

Contact the study team to confirm eligibility.