Trial · Interventional

CompletedPhase 3Results postedRegistry data

Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis

NCTNCT00439244Other idCZOL446H2409

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 412 participants (actual)
Sponsor: Novartis · Industry
Design: Randomized · Quadruple masking
Countries: 4 countries
United States, Belgium, Germany, Spain
Start: Dec 2006
Primary completion: Feb 2009
Completion: Feb 2009
First posted: 23 Feb 2007 (estimated)
Last update posted: 20 Apr 2011 (estimated)
Conditions: Osteoporosis

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20062007200820092010

Ph 3
Efficacy Study of Zoledronic Acid and Teriparatide Combination Therapy in Women With Osteoporosis
NCT00439244
Dec 2006 to Feb 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to assess the effects of zoledronic acid administered at the same time with teriparatide compared to zoledronic acid alone and teriparatide alone on bone mineral density (BMD) gain in the lumbar spine and total hip

Interventions

Zoledronic acidDrug
PlaceboDrug
TeriparatideDrug

Arms3

Active comparator
Zoledronic acid plus teriparatide
Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
Experimental
Zoledronic acid
Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
Active comparator
Placebo zoledronic acid plus teriparatide
Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52
Time frame · Baseline through Week 52
Registry description
BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.

Secondary outcomes(4)

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26
Time frame · Baseline through Week 13 and Week 26
Registry description
BMD measurements of the lumbar spine (L1-L4) by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the Final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.
Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52
Time frame · Baseline through Week 13, Week 26 and Week 52
Registry description
BMD measurements of the total hip by Dual X-ray absorptiometry (DXA) were performed on all patients at screening, and Weeks 13, 26, and 52 (or early termination). Every attempt was made to obtain the BMD measurements at the scheduled visit. If this was not possible, a BMD measurement ± 7 days from the scheduled visit was obtained. For the final DXA at Week 52, the window was 10 - 15 days prior to the final study visit. BMD scans were acquired locally and all results sent to a central reader for evaluation.
Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP)
Time frame · At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52
Registry description
Specialized tests for markers of bone formation such as n-terminal propeptide of type I collagen (P1NP) were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum P1NP was determined by the central laboratory.
Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx)
Time frame · At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52
Registry description
Specialized tests for markers of bone formation such as β-CTx were performed at Baseline, and Weeks 4, 8, 26, 39, and 52. The amount of serum β-CTx was determined by the central laboratory.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline through Week 52

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 52

Group	Value (Percent change)	Spread
Zoledronic Acid Plus Teriparatide	7.51	0.414
Zoledronic Acid	4.37	0.401
Placebo Zoledronic Acid Plus Teriparatide	7.05	0.398

Secondary and other outcome results(4)

Secondary outcomeLeast squares mean· Baseline through Week 13 and Week 26

Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Week 13 and Week 26

Group	Value (Percent Change)	Spread
Zoledronic Acid Plus Teriparatide	4.65	0.302
Zoledronic Acid	2.97	0.297
Placebo Zoledronic Acid Plus Teriparatide	2.88	0.297

Secondary outcomeLeast squares mean· Baseline through Week 13, Week 26 and Week 52

Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 13, Week 26 and Week 52

Group	Value (Percent Change)	Spread
Zoledronic Acid Plus Teriparatide	2.54	0.222
Zoledronic Acid	1.53	0.216
Placebo Zoledronic Acid Plus Teriparatide	0.75	0.216

Secondary outcomeMean· At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52

Bone Resorption and Formation Biochemical Markers : N-terminal Propeptide of Type I Collagen (P1NP)

Group	Value (ng/mL)	Spread
Zoledronic Acid Plus Teriparatide	52.72	24.815
Zoledronic Acid	53.64	29.233
Placebo Zoledronic Acid Plus Teriparatide	55.69	28.631

Secondary outcomeMean· At Baseline, Week 4, Week 8, Week 26, Week 39 and Week 52

Bone Resorption and Formation Biochemical Markers : Beta C-terminal Telopeptides of Type I Collagen (β-CTx)

Group	Value (ng/mL)	Spread
Zoledronic Acid Plus Teriparatide	0.45	0.191
Zoledronic Acid	0.44	0.218
Placebo Zoledronic Acid Plus Teriparatide	0.46	0.222

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Zoledronic AcidZoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.	–	20 / 137	115 / 137
Zoledronic Acid Plus TeriparatideZoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.	–	13 / 137	118 / 137
Placebo Zoledronic Acid Plus TeriparatidePlacebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.	–	15 / 137	96 / 137

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 45 Years up to 89 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion criteria: * Postmenopausal (PMO) women between 45 and 89 years of age. * Bone mineral density T score of -2.5 or less at femoral neck, total hip or lumbar spine OR * Bone mineral density T score of -2.0 or less at femoral neck, total hip or lumbar spine with at least one documented osteoporotic vertebral fracture or a previously documented history of an osteoporotic clinical non-vertebral fracture not due to excessive trauma Exclusion criteria: * Any prior use of strontium * Any past or active kidney disease or problems with kidney function * Prior treatment with any intravenous (i.v.) or oral bisphosphonate (such as but not limited to alendronate, risedronate and pamidronate) longer than 3 months consecutively. If bisphosphonate exposure is less than or equal to 3 months , a washout period of 1 year to randomization is required * Calcium levels in blood within the normal range * Normal liver function * Non-osteoporotic forms of metabolic bone disease such as and not limited to Paget's disease of bone, osteomalacia, osteogenesis imperfecta or multiple myeloma * Less than 3 evaluable lumbar (L1-L4) vertebrae for dual energy x-ray absorptiometry (DXA) measurement * Treatment with osteoporotic therapies such as raloxifene, calcitonin or Hormone Replacement Therapy within 3 months of randomization * Allergy or previous exposure to teriparatide Other protocol-defined inclusion/exclusion criteria may apply

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