Randomized Teriparatide [human parathyroid hormone (PTH) 1-34] Once-Weekly Efficacy Research (TOWER) trial for examining the reduction in new vertebral fractures in subjects with primary osteoporosis and high fracture risk.

Nakamura T, Sugimoto T, Nakano T, Kishimoto H, Ito M, Fukunaga M, Hagino H, Sone T, Yoshikawa H, Nishizawa Y, Fujita T, Shiraki M

The Journal of clinical endocrinology and metabolism20 Jun 2012Cited by 204 (Europe PMC)

PMID22723322DOI10.1210/jc.2011-3479PepBankPUB-22723322

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Summary

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Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese patients with osteoporosis and prevalent vertebral fracture, weekly teriparatide reduced new vertebral fracture risk versus placebo.
In plain wordsIn patients with osteoporosis and existing spinal fractures, weekly teriparatide reduced new spinal fractures compared with placebo.
Peptide
Teriparatide (PTH 1-34)
Outcome
DecreaseNew vertebral fracture
Study
n = 578
Comparator
Placebo
Analysis
Primary
Outcome group
Bone and joint · Musculoskeletal
Studied dose
56.5 μg once weekly · subcutaneous · 72 weeksAs given in this study (human).
Measurements
Cumulative fracture incidence
3.1%
teriparatide
Cumulative fracture incidence
14.5%
placebo
Relative risk
0.2 ratio
teriparatide versus placebo
Source sentences
Summary
Once-weekly injections of teriparatide reduced the risk of new vertebral fracture with a cumulative incidence of 3.1% in the teriparatide group, compared with 14.5% in the placebo group (P < 0.01), and a relative risk of 0.20 (95% confidence interval, 0.09 to 0.45).
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, multicenter, double-blind, placebo-controlled trial conducted in Japan, the incidence of morphological vertebral fractures by radiographs was assessed.
Summary · context
Subjects were 578 Japanese patients between the ages of 65 and 95 yr who had prevalent vertebral fracture.
Summary · context
Subjects were randomly assigned to receive once-weekly s.c. injections of teriparatide (56.5 μg) or placebo for 72 wk.
Report a problemFND-2272332201
02HumanRandomized controlled trialEfficacy outcome
In Japanese patients with osteoporosis, teriparatide increased lumbar spine bone mineral density compared with placebo.
In plain wordsIn patients with osteoporosis, teriparatide increased lower spine bone density compared with placebo.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseLumbar spine bone mineral density
Study
n = 578
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
56.5 μg once weekly · subcutaneous · 72 weeksAs given in this study (human).
Measurements
BMD increase
6.4%
lumbar spine versus placebo at 72 weeks
Source sentences
Summary
At 72 wk, teriparatide administration increased bone mineral density by 6.4, 3.0, and 2.3% at the lumbar spine, the total hip, and the femoral neck, respectively, compared with the placebo (P < 0.01).
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, multicenter, double-blind, placebo-controlled trial conducted in Japan, the incidence of morphological vertebral fractures by radiographs was assessed.
Summary · context
Subjects were 578 Japanese patients between the ages of 65 and 95 yr who had prevalent vertebral fracture.
Summary · context
Subjects were randomly assigned to receive once-weekly s.c. injections of teriparatide (56.5 μg) or placebo for 72 wk.
Report a problemFND-2272332202
03HumanRandomized controlled trialEfficacy outcome
In Japanese patients with osteoporosis, teriparatide increased total hip bone mineral density compared with placebo.
In plain wordsIn patients with osteoporosis, teriparatide increased total hip bone density compared with placebo.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseTotal hip bone mineral density
Study
n = 578
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
56.5 μg once weekly · subcutaneous · 72 weeksAs given in this study (human).
Measurements
BMD increase
3%
total hip versus placebo at 72 weeks
Source sentences
Summary
At 72 wk, teriparatide administration increased bone mineral density by 6.4, 3.0, and 2.3% at the lumbar spine, the total hip, and the femoral neck, respectively, compared with the placebo (P < 0.01).
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, multicenter, double-blind, placebo-controlled trial conducted in Japan, the incidence of morphological vertebral fractures by radiographs was assessed.
Summary · context
Subjects were 578 Japanese patients between the ages of 65 and 95 yr who had prevalent vertebral fracture.
Summary · context
Subjects were randomly assigned to receive once-weekly s.c. injections of teriparatide (56.5 μg) or placebo for 72 wk.
Report a problemFND-2272332203
04HumanRandomized controlled trialEfficacy outcome
In Japanese patients with osteoporosis, teriparatide increased femoral neck bone mineral density compared with placebo.
In plain wordsIn patients with osteoporosis, teriparatide increased bone density at the femoral neck compared with placebo.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseFemoral neck bone mineral density
Study
n = 578
Comparator
Placebo
Outcome group
Bone and joint · Musculoskeletal
Studied dose
56.5 μg once weekly · subcutaneous · 72 weeksAs given in this study (human).
Measurements
BMD increase
2.3%
femoral neck versus placebo at 72 weeks
Source sentences
Summary
At 72 wk, teriparatide administration increased bone mineral density by 6.4, 3.0, and 2.3% at the lumbar spine, the total hip, and the femoral neck, respectively, compared with the placebo (P < 0.01).
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, multicenter, double-blind, placebo-controlled trial conducted in Japan, the incidence of morphological vertebral fractures by radiographs was assessed.
Summary · context
Subjects were 578 Japanese patients between the ages of 65 and 95 yr who had prevalent vertebral fracture.
Summary · context
Subjects were randomly assigned to receive once-weekly s.c. injections of teriparatide (56.5 μg) or placebo for 72 wk.
Report a problemFND-2272332204
05HumanRandomized controlled trialSafety outcome
In Japanese patients with osteoporosis, adverse events were more frequent with teriparatide than placebo but generally mild and tolerable.
In plain wordsIn patients with osteoporosis, adverse events occurred more often with teriparatide than placebo but were generally mild and tolerable.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseAdverse events
Study
n = 578
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
56.5 μg once weekly · subcutaneous · 72 weeksAs given in this study (human).
Source sentences
Summary
Adverse events (AE) and the dropout rates by AE were more frequently experienced in the teriparatide group, but AE were generally mild and tolerable.
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, multicenter, double-blind, placebo-controlled trial conducted in Japan, the incidence of morphological vertebral fractures by radiographs was assessed.
Summary · context
Subjects were 578 Japanese patients between the ages of 65 and 95 yr who had prevalent vertebral fracture.
Summary · context
Subjects were randomly assigned to receive once-weekly s.c. injections of teriparatide (56.5 μg) or placebo for 72 wk.
Report a problemFND-2272332205
06HumanRandomized controlled trialSafety outcome
In Japanese patients with osteoporosis, dropout due to adverse events was more frequent with teriparatide than placebo.
In plain wordsIn patients with osteoporosis, more patients stopped teriparatide because of adverse events than stopped placebo.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseDropout due to adverse events
Study
n = 578
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
56.5 μg once weekly · subcutaneous · 72 weeksAs given in this study (human).
Source sentences
Summary
Adverse events (AE) and the dropout rates by AE were more frequently experienced in the teriparatide group, but AE were generally mild and tolerable.
3 context sentences(design, population, supporting numbers)
Summary · context
In this randomized, multicenter, double-blind, placebo-controlled trial conducted in Japan, the incidence of morphological vertebral fractures by radiographs was assessed.
Summary · context
Subjects were 578 Japanese patients between the ages of 65 and 95 yr who had prevalent vertebral fracture.
Summary · context
Subjects were randomly assigned to receive once-weekly s.c. injections of teriparatide (56.5 μg) or placebo for 72 wk.
Report a problemFND-2272332206

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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