Two-year clinical outcome of denosumab treatment alone and in combination with teriparatide in Japanese treatment-naive postmenopausal osteoporotic women.

Nakamura Y, Suzuki T, Kamimura M, Ikegami S, Murakami K, Uchiyama S, Taguchi A, Kato H

Bone research13 Jun 2017Cited by 26 (Europe PMC)

PMID28690911PMCIDPMC5494185DOI10.1038/boneres.2016.55PepBankPUB-28690911

Summary

This randomized prospective study aimed to evaluate the clinical outcome of denosumab treatment alone and in combination with teriparatide in treatment-naive postmenopausal Japanese female patients with osteoporosis. Thirty patients were randomly assigned to two groups: (1) denosumab group (denosumab alone, n=13); and (2) combination group (denosumab+teriparatide, n=17). Serum bone-specific alkaline phosphatase (BAP), serum tartrate-resistant acid phosphatase (TRACP)-5b, urinary cross-linked N-terminal telopeptides of type I collagen (NTX), and bone mineral density (BMD) of L1-4 lumbar vertebrae (L-BMD) and bilateral total hips (H-BMD) were determined at the first visit and at various time points up to 24 months post-treatment to determine percentage changes. Serum TRACP-5b and urinary NTX were equally suppressed in both groups and maintained at low levels, with slight increases at 12, 18 and 24 months. BAP was significantly decreased in both groups from 4 to 24 months, with significant differences between the groups at 4, 8 and 15 months (P<0.05). L-BMD was significantly increased at most time points in both groups, with a significant difference between the combination group and denosumab group at 24 months (17.2% increase versus 9.6% increase; P<0.05). There was no significant difference in H-BMD between the two groups, although the levels tended to be higher in the combination group than in the denosumab group (9.5% increase versus 5.6% increase). These findings suggest that denosumab+teriparatide combination therapy may represent an important treatment for primary osteoporotic patients at high risk of vertebral fracture.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese postmenopausal women with osteoporosis, adding teriparatide to denosumab did not alter TRACP-5b suppression versus denosumab alone.
In plain wordsIn Japanese postmenopausal women with osteoporosis, TRACP-5b suppression was similar with combined teriparatide and denosumab versus denosumab alone.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeSerum TRACP-5b
Study
n = 30
Comparator
Denosumab alone
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated
Source sentences
Summary
Serum TRACP-5b and urinary NTX were equally suppressed in both groups and maintained at low levels, with slight increases at 12, 18 and 24 months.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized prospective study aimed to evaluate the clinical outcome of denosumab treatment alone and in combination with teriparatide in treatment-naive postmenopausal Japanese female patients with osteoporosis.
Summary · context
Thirty patients were randomly assigned to two groups: (1) denosumab group (denosumab alone, n=13); and (2) combination group (denosumab+teriparatide, n=17).
Show in the study text Report a problemFND-2869091101
02HumanRandomized controlled trialEfficacy outcome
In Japanese postmenopausal women with osteoporosis, adding teriparatide to denosumab did not alter urinary NTX suppression versus denosumab alone.
In plain wordsIn Japanese postmenopausal women with osteoporosis, urinary NTX suppression was similar with combined teriparatide and denosumab versus denosumab alone.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeUrinary NTX
Study
n = 30
Comparator
Denosumab alone
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated
Source sentences
Summary
Serum TRACP-5b and urinary NTX were equally suppressed in both groups and maintained at low levels, with slight increases at 12, 18 and 24 months.
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized prospective study aimed to evaluate the clinical outcome of denosumab treatment alone and in combination with teriparatide in treatment-naive postmenopausal Japanese female patients with osteoporosis.
Summary · context
Thirty patients were randomly assigned to two groups: (1) denosumab group (denosumab alone, n=13); and (2) combination group (denosumab+teriparatide, n=17).
Show in the study text Report a problemFND-2869091102
03HumanRandomized controlled trialEfficacy outcome
In Japanese postmenopausal women with osteoporosis, BAP fell in both arms, with between-group differences at several visits whose direction was unstated.
In plain wordsIn Japanese postmenopausal women with osteoporosis, BAP fell with combined teriparatide and denosumab and denosumab alone, with differences at some visits.
Peptide
Teriparatide (PTH 1-34)
Outcome
Direction not reportedBone-specific alkaline phosphatase
Study
n = 30
Comparator
Denosumab alone
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated
Source sentences
Summary
BAP was significantly decreased in both groups from 4 to 24 months, with significant differences between the groups at 4, 8 and 15 months (P<0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized prospective study aimed to evaluate the clinical outcome of denosumab treatment alone and in combination with teriparatide in treatment-naive postmenopausal Japanese female patients with osteoporosis.
Summary · context
Thirty patients were randomly assigned to two groups: (1) denosumab group (denosumab alone, n=13); and (2) combination group (denosumab+teriparatide, n=17).
Show in the study text Report a problemFND-2869091103
04HumanRandomized controlled trialEfficacy outcome
In Japanese postmenopausal women with osteoporosis, adding teriparatide to denosumab increased lumbar BMD more than denosumab alone at 24 months.
In plain wordsIn Japanese postmenopausal women with osteoporosis, adding teriparatide to denosumab increased lumbar bone density more than denosumab alone.
Peptide
Teriparatide (PTH 1-34)
Outcome
IncreaseLumbar BMD
Study
n = 30
Comparator
Denosumab alone
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated
Measurements
L-BMD change at 24 months
17.2%
combination group
L-BMD change at 24 months
9.6%
denosumab group
Source sentences
Summary
L-BMD was significantly increased at most time points in both groups, with a significant difference between the combination group and denosumab group at 24 months (17.2% increase versus 9.6% increase; P<0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized prospective study aimed to evaluate the clinical outcome of denosumab treatment alone and in combination with teriparatide in treatment-naive postmenopausal Japanese female patients with osteoporosis.
Summary · context
Thirty patients were randomly assigned to two groups: (1) denosumab group (denosumab alone, n=13); and (2) combination group (denosumab+teriparatide, n=17).
Show in the study text Report a problemFND-2869091104
05HumanRandomized controlled trialEfficacy outcome
In Japanese postmenopausal women with osteoporosis, adding teriparatide to denosumab did not significantly change hip BMD versus denosumab alone.
In plain wordsIn Japanese postmenopausal women with osteoporosis, adding teriparatide to denosumab did not significantly change hip bone density versus denosumab alone.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeTotal hip BMD
Study
n = 30
Comparator
Denosumab alone
Outcome group
Bone and joint · Musculoskeletal
Studied dose
Dose not stated
Measurements
H-BMD change
9.5%
combination group
H-BMD change
5.6%
denosumab group
Source sentences
Summary
There was no significant difference in H-BMD between the two groups, although the levels tended to be higher in the combination group than in the denosumab group (9.5% increase versus 5.6% increase).
2 context sentences(design, population, supporting numbers)
Summary · context
This randomized prospective study aimed to evaluate the clinical outcome of denosumab treatment alone and in combination with teriparatide in treatment-naive postmenopausal Japanese female patients with osteoporosis.
Summary · context
Thirty patients were randomly assigned to two groups: (1) denosumab group (denosumab alone, n=13); and (2) combination group (denosumab+teriparatide, n=17).
Show in the study text Report a problemFND-2869091105

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

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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

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